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Beta-Cath™ 3.5F User`s Manual

1. Delivery of the NoN Active Source Train 1 Ensure that the hemostatic valve is open 2 Ensure that Power is ON 3 Slide the Gate Control Switch forward until the Blue Arrow aligns with REN Note If the Gate Control Switch cannot be moved to the open position and the green SOURCES IN LED is illu minated then move the Gate Control Switch back to the fully closed position and power down the Transfer Device Restart the Transfer Device and proceed as normal 4 Move the Fluid Control Lever to EZE 5 While observing with fluoroscopy depress the syringe plunger to transport non active Source Train to interventional injury site of the Delivery Catheter All three Amber vi Pressure Indicator lights should be illuminated while SENDING the NON ACTIVE Source 50 g Novoste D03745 Rev D 03 08 ETA CATHP R Optional Instructions continued Train An audible click will be heard as the NON ACTIVE Source Train leaves the Source Chamber 6 Use fluoroscopy to confirm proper placement of the entire ROR ACTIN Source Train at the interventional injury site a In the event that the non active Source Train can not be confirmed to have reached the injury site immediately perform the following maneuver to reposition the non active Source Train e Confirm the hemostatic valve is open e Confirm the Fluid Control Lever
2. Exchange of Battery Power Source Transfer Device Controls and Indicators Figure 4 Beta Cath 3 5F System Table 8 Transfer Device Controls and Figure 5 ACTIVE Beta Cath 3 5F System Compatible Transfer Device 60 mm shown Flows sm AE pw E B Radioactive Sealed Source Device Leak Test Procedure C Therapy Planning ee Figure IST Marker Positions Figure 7 Appropriate Radiation Coverage D Surveillance of the Cath Lab Room E Delivery Catheter Inspection Preparation F Placement of the Delivery Catheter Figure 8 Delivery Catheter Positioning Using the IST aa eene eren ST Removal TO ACTIVE Transfer Device Preparation with the 6 Rail 3 5F Delivery Catheter Figure 9 Sterile Figure 10 Fluid Management System ACTIVE Transfer Device Preparation with the amp Rail V 3 5F XL Delivery Catheter ACTIVE Transfer Device MD EUM Delivery of the RS ro semis dare ipa nia i Source pen Delivery Cat
3. The Beta Cath System is not indicated for pullback stepping 1 D03745 Rev D 03 08 This page intentionally left blank 2 D03745 Rev D 03 08 ETA CATHP I Introduction How To Use This Manual This manual is intended to guide clinicians that have com pleted the authorized formal training program for the Novoste Beta Cath 3 5F System Please contact Best Vascular to schedule a training session Read this manual completely before system use and keep it readily avail able for reference This manual contains recommended safety procedures as minimum safety guidelines devel opec from good clinical practices and the As Low As Reasonably Achievable ALARA radiation exposure philosophy Definitions Indications Indications are the general descriptions of the disease or condition the device can be used to treat prevent cure or mitigate including a description of the patient population for which the device is intended Contraindications Contraindications are condi tions under which the device should NOT be used because the risk of use outweighs any possible bene fit Special Considerations Patient circumstances or conditions which merit additional attention by the physician Adverse Events Undesirable effects reasonably associated with the use of the device A serious adverse event refers to an adverse experience that is life threatening results in permanent impairment of a body fun
4. Fluoroscopic View of Delivery Catheter and IST Internal Marker Stop Catheter s gt Tip Stop Catheter Marker IST 60mm Marker IST 30mm 40mm Marker Marker IST IST Provide the interventional injury site measurement length and diameter and desired margin coverage to the Radiation Oncologist Therapist for selection of the appropriate Transfer Device Source Train and determi nation of treatment time 41 D03745Rev D 03 08 ETA CATH G IST Removal CARD 1 Once the Delivery Catheter has been positioned with the Indicator of Source Train IST across the interven tional injury site close the hemostatic valve 2 Grasp the proximal end of the IST and gently with draw the IST far enough into the guiding catheter to approximately the projection of the aortic arch and readvance it at least twice to find any potential obsta cle for the active Source Train PRECAUTION f resistance is felt and believed to be due to patient anatomy withdraw the entire Delivery Catheter including IST and optimize guiding catheter selection and or perform a re intervention at the target lesion Reposition the Delivery Catheter including IST per Section F Placement of Delivery Catheter If resis tance is felt and believed to be due to the Delivery Catheter remove the entire Delivery Catheter including IST from the patient and return the Delivery Catheter to Best Va
5. PRECAUTION Do not use the Delivery Catheter if there is evidence of fluid leakage other than at the IST hub vent position 7 Withdraw the IST hub from the tip of the Delivery Catheter Proprietary Connector sufficiently to expose the two o rings of the Proprietary Connector Wet the orings of the Delivery Catheter Proprietary Connector with Sterile Water for Irrigation and reattach the IST hub onto the tip of the Delivery Catheter Proprietary Connector 8 Visually confirm that the IST is fully reinserted into the Delivery Catheter and seated against its internal distal marker stop F Placement of Delivery Catheter CARD WARNING Use of an Internal Mammary IM Artery Guide Catheter may impede the path of the ACTIVE Source Train and may cause unintentional exposure of radiation and or unintended results 1 After completing the intervention to the target lesion remove interventional devices leaving the guidewire and guiding catheter in place 2 Wipe the guidewire remaining outside the patient with a sterile gauze pad soaked in saline to remove any blood or contrast media that may be on the surface 3 Review films of the contrast medium injections noting the positions of all interventional devices used to define the entire interventional injury site 4 Advance the Delivery Catheter over the 0 014 guidewire through the guiding catheter to the inter ventional injury site A depth marker band has been
6. 18 4 and 23 Gray reflect the NIST recommended adjustments to the documented doses as described in Technical Report DSGN 0311 A and are equivalent to the 16 and 20 Gray documented doses described in the START trial Each Source Train is shipped with a Calibration Certificate Each Calibration Certificate provides the cali brated dose rate for the Source Train at 2 mm from the centerline in water and the recommended dose and treat ment times dwell times for reference vessel diameter ranges The recommended dose and treatment times provided have accounted for typical stent attenuation as was studied in the clinical trial The Calibration Certificate should be followed for dose and associated treatment times Note Two separate tables of dose and treat ment times are provided on the Transfer Device Calibration Certificate The first table provides the recommended dose and treatment times for the first 6 months of use The second table provides the recommended dose and treatment times for the remainder of the Transfer Device s use period Please ensure the proper table of dose and treatment times is followed ACTIVE The appropriate Source Train length 30 mm 40 mm or 60 is selected by determining the entire injury length and desired margin The Interventional Cu will determine the size and length of the entire injury site Entire injury site is defined as the entire Novoste vessel segment that is injured b
7. Arrhythmia Aneurysm Arterial Damage Dissection or Perforation e Excessive Radiation Exposure to Patient Staff Vascular Access Site Hematoma Arterial Damage e Contrast Induced Nephrotoxicity Coronary Artery Bypass Graft Surgery Neurologic Complications Thrombosis Allergic Reactions Restenosis Infection Myocardial Infarction Stroke Death Thrombotic Occlusion Renal Insufficiency Coronary Artery Bypass Graft Surgery Slow Flow Phenomenon AV Fistula Pseudoaneurysm Left Ventricular Dysfunction Systemic Atheroembolization Endocarditis Distal Embolizations Vasospasm Arterial Perforation Retroperitoneal Hematoma Beta Cath System is not indicated for pullback stepping e Novoste 7 D03745 Rev D 03 08 ETA CATH Antiplatelet Therapy To minimize the risk of thrombosis when new stents are implanted in conjunction with radiation therapy a mini mum of three 3 months antiplatelet therapy is recom mended with the 30 and 40 mm Beta Cath 3 5F System and a minimum of six 6 months with the 60 mm Beta Cath 3 5F System If a new stent is not implanted in conjunction with radiation therapy antiplatelet therapy should be administered at the physician s discretion Novoste START Trial The START STents And Radiation Therapy Trial a multicenter randomized placebo controlled trial began in September 1998 The START Trial primarily studied the tre
8. 77 187 0 3 0 24 0 51 27 0 35 576 18 4 _ 0 0000 8 Month Analysis Segment Binary Restenosis Rate 28 8 57 198 45 2 85 188 0 6 0 49 0 83 16 4 25 9 6 9 0 0008 TLRFree at 240 Days 86 4 75 6 1 14 1 03 1 27 10 8 2 5 19 0 0 0090 TVR Free at 240 Days 83 5 73 8 1 13 1 01 1 27 9 7 1 1 18 3 0 0283 TVF Free at 240 Days 81 4 72 2 1 13 1 00 1 27 9 2 0 3 18 1 0 0393 MACE Free at 240 Days 81 4 72 2 1 13 1 00 1 27 9 2 0 3 18 1 0 0393 Target Lesion Success 99 6 243 244 99 1 230 232 1 0 0 99 1 02 0 5 1 0 1 9 0 5332 Procedure Success 97 1 237 244 97 0 225 232 1 0 0 97 1 03 0 1 2 9 3 2 0 9237 Device Success 98 4 240 244 97 8 227 232 1 0 0 98 1 03 0 5 1 9 3 0 0 6796 PostProcedure Stent Segment Minimal Lumen Diameter MLD in mm Meant SD N 2 17 0 42 242 2 15 0 42 229 0 02 0 06 0 09 0 6503 Range min max 1 12 3 47 1 20 3 40 PostProcedure Analysis Segment Minimal Lumen Diameter MLD in mm SD N 1 94 0 39 243 1 94 0 41 230 0 00 0 08 0 07 0 9058 Range min max 1 03 3 02 0 98 3 10 PostProcedure Stent Segment Percent Diameter Stenosis DS SD N 22 9 13 5 242 22 9 12 9 229 0 0 2 4 2 4 0 9972 Range min max 31 1 53 2 19 676 51 9 PostProcedure Analysis Segment Percent Diameter Stenosis DS SD N 31 4 10 2 243 30 7 11 0 230 0 7 1 2 2 6 0 4800 Range
9. D03745 Rev D 03 08 In Hospital MACE Death Q wave or non Q wave MI emergent CABG or target vessel revascularization prior to discharge as determined by the independent Clinical Events Committee Outof Hospital Death Q wave or non Q wave emergent CABG or target vessel revascularization from hospital discharge through the 240 day contact as determined by the independent Clinical Events Committee Stent thrombosis was defined as angiographic thrombus or subacute closure within the target vessel at the time of the clinically driven angiographic restudy for documented ischemia chest pain and ECG changes Any death not attributed to a non cardiac cause within the first 30 days was considered a surrogate for thrombosis in the absence of documented angiographic stent patency Site thrombosis was defined as myocardial infarction attributable to the target vessel with angiographic documenta tion sitereported or by QCA of thrombus or total occlusion at the target site gt 30 days after the index procedure in the absence of an intervening revascularization of the target vessel Aneurysm was defined as an expansion of the lumen by at least 20 compared with the normal lumen dimensions in the treatment region analyzed segment that extends with a wide or narrow mouth beyond the apparent normal contour Total Occlusion An MLD of zero at follow up as assessed by QCA Gn Novoste Table 3 Principal Effectiveness and Saf
10. provided approximately 100 cm from the distal tip of the Delivery Catheter as a position reference a Novoste PRECAUTION Always advance the Delivery Catheter with the IST in position within the Delivery Catheter PRECAUTION Always advance or withdraw the Delivery Catheter slowly and observe under fluoroscopy WARNING Never advance or withdraw the Delivery Catheter against resistance If any resistance is felt stop immediately and determine the cause of resistance before proceeding Catheter damage and or patient injury could occur PRECAUTION Do not advance the Delivery Catheter over the floppy portion of the guidewire as the guidewire may prolapse when the Delivery Catheter is withdrawn If this occurs attempt to resolve the prolapse by gently pulling back on the guidewire while simultane ously advancing the catheter If the prolapse persists disengage the Delivery Catheter from the guidewire by continuing to advance the Delivery Catheter while gen tly pulling back on the guidewire 5 Under fluoroscopy use the IST to position the Delivery Catheter across the interventional injury site Confirm the appropriate Transfer Device Source Train Length by referencing the IST marker 30 mm 40 mm or 60 mm that provides complete injuy length and desired margin coverage see Figure 8 Figure 8 Delivery Catheter Positioning Using the IST Active Train Length 60mm 40mm 30mm
11. 0 9 0 29 2 76 0 4 4 3 3 6 0 8473 Numbers are counts sample size or Mean SD CI Confidence Interval MACE free Freedom from death MI emergent CABG and target vessel revascularization Relative Risk START 40 20 START Placebo SE sqri 1 p1 n3 1 1 P2 n21 Cl RR exp 1 96 SE Difference START 40 20 START Placebo SE sqrt p1 q n p2 q2 n2 CI Diff 1 96 SE N A Not applicable Target Lesion Success Attainment of a final residual stenosis of lt 50 by using any percutaneous method If QCA was not available the visual estimate of diameter stenosis was used Procedure Success Attainment of a final residual stenosis of lt 50 by QCA using any percutaneous method and no in hospital major adverse cardiac events If QCA was not available the visual estimate of diameter stenosis was used Device Success Successful delivery of the Beta Cath System Stent segment was defined as the area confined to the proximal and distal borders of the stent Analysis segment was defined as the segment that extends 5 mm proximal and distal to the radiated or injured landmark whichever was longest in length Survival estimates from Kaplan Meier method Standard error estimate from Peto formula TLR free Freedom from target lesion revascularization TVR free Freedom from target vessel revascularization TVF free Freedom from death MI and target vessel revascularization 18
12. 0060 134 139 244 244 378 383 7 27 0 07 Procedure Success 89 9 97 0 94 3 0 93 0 87 0 98 7 13 0 0088 124 138 225 232 349 370 13 22 1 03 Brachytherapy Success 99 3 N A 99 3 N A N A N A 138 139 138 139 MACE Free 82 1 74 1 77 0 1 11 0 99 1 24 7 95 0 0937 110 134 172 232 282 366 1 26 17 16 TVR Free 85 1 75 9 79 2 1 12 1 01 1 24 9 21 0 43 17 99 0 0444 114 134 176 232 290 366 MACE 17 9 25 9 23 0 0 69 7 95 0 0937 24 134 60 232 84 336 0 45 1 06 17 16 1 26 TVR 14 9 24 1 20 8 0 62 0 39 0 98 9 21 0 0444 20 134 56 232 76 366 17 99 0 43 In Hospital MACE 2 2 2 2 5 232 2 2 1 00 0 24 4 13 0 00 gt 0 9999 3 139 8 371 3 64 3 64 Out of Hospital MACE 16 4 24 1 21 3 0 68 7 72 0 0867 22 134 56 232 78 366 0 44 1 06 l 16 68 1 24 CORE LAB SUBSET ANALYSIS In Analysis Segment 0 15 0 71 0 55 0 59 N A N A 0 40 0 59 0 21 0 0006 Late Loss 49 188 Stent Segment Late Loss 0 11 0 90 0 67 0 61 N A N A 0 56 0 77 0 35 0 0001 49 187 In Analysis Segment 1 34 7 32 0 84 3 41 N A N A 2 18 3 60 0 76 0 0476 Late Loss Index 49 187 Stent Segment Late Loss 0 01 0 60 0 57 0 60 N A N A 0 56 0 75 0 37 lt 0001 Index 49 186 In Analysis Segment 28 6 45 2 41 8 0 63 0 40 1 01 16 64 0 0502 Binary Restenosis Rate 14 49 85 188 99 237 32 56 0 72 Stent Segment Binary 20 4 41 2 36
13. 12 11 10 3 74 11 13 6 Death 0 0 0 1 0 4 2 22 3 45 5 5 7 3 3 0 1 14 2 24 3 28 1 12 1 12 i 4 1 7 30 fo o 2 2 23 2 200 o o of 2 la alo 0 TLR 32 13 1 52 224 1 14 1 15 3 34 2 20 1 14 2 24 2 19 1 12 6 7 4 Total TVR 39 16 0 56 24 1 4 43 2 3 0 4 46 4 40 3 41 1 12 5 47 4 47 2 25 TVR CABG 21 86 24 10 3 1 14 1 15 3 34 0 0 0 0 0 0 0 0 1 12 0 0 Road 78 fee 2 1 sfa 55 2 za a afa a Aneurysm 1 198 0 5 0 188 0 0 0 0 0 0 1 14 0 0 0 0 0 0 0 0 0 0 0 0 Table C4 Comparison of Efficacy Outcomes at 3 4 and 5 Yearst START Placebo START Sr 90 START Placebo START Sr 90 START Placebo START Sr 90 3 Year 3 Year 4 Year 4 Year 5 Year 5 Year versus versus Versus versus Versus versus START Sr 90 START 40 Sr 90 START Sr 90 START 40 Sr 90 START Sr 90 START 40 Sr 90 Variable 3 Year 3 Year 4 Year 4 Year 5 Year 5 Year MACE 0 1939 0 6011 0 7937 0 0119 0 6096 0 4979 TVR 1 0000 1 0000 1 0000 1 0000 1 0000 0 6722 Table C5 Cumulative 3 4 and 5 Year Safety and Efficacy Outcomes START and START 40 PAS Calculated using the Kaplan Meier method Original Original PAS START PASSTART PAS START40 PAS START PAS START PAS PAS START PAS START PAS START START Sr 90 Placebo Sr 90 Sr 90 Placebo START40 51 90 Placebo START40 Sr 90 Placebo Events Events Events Events Events Sr 90 Events Events Sr 90 Events Events Reported At Reported At Reported At Reported At Reported At Events Reported At Reported At Events Reported Reported 3 years 3 years 3 years 4 ye
14. 14 2 196 30 7 11 0 230 2 4 0 0 4 9 0 0461 Range min max 3 1 74 0 5 8 62 5 Follow Up Stent Segment Minimal Lumen Diameter MLD in mm Means SD NJ 1 85 0 65 149 1 47 0 60 187 0 38 0 24 0 51 0 0000 Range min max 0 00 3 41 0 00 2 65 Follow Up Analysis Segment Minimal Lumen Diameter MLD in mm Mean SD N 1 60 0 58 150 1 41 0 58 186 0 19 0 06 0 31 0 0034 Range min max 0 00 3 16 0 00 2 66 Follow Up Stent Segment Percent Diameter Stenosis DS Means SD NJ 30 7 t 23 1 149 47 9 20 8 187 17 2 21 9 12 5 0 0000 Range min max 8 075 100 0 4 4 100 0 Follow Up Analysis Segment Percent Diameter Stenosis DS Means SD N 40 295 20 1 150 50 1 19 7 188 9 9 14 2 5 7 0 0000 Range min 2 4 100 0 13 4 100 0 Safety Measures and Other Clinical Events to 240 days In Hospital MACE 1 9 47207 2 2 5 232 0 9 0 24 3 29 0 2 2 9 2 4 0 8994 Out ofHospital MACE to 240 Days 17 9 37 207 24 1 56 232 0 70 51 1 07 6 395 14 3 1 3 0 1089 In and Outof Hospital MACE to 240 Days 19 3 40 207 25 9 60 232 0 7 0 52 1 06 6 5 14 3 1 3 0 1030 Aneurysm 0 7 1 150 0 0 0 188 0 7 0 6 2 0 0 2622 Stent Thrombosis to 30 days 0 0 0 207 0 4 1 232 0013 0 4 1 3 0 4 0 3443 Site Thrombosis Days 31 240 1 0 2 207 0 0 0 232 TA 1 0 0 4 2 3 0 1335 Total Occlusions Angiographic 3 3 5 150 3 7 7 188
15. 17 9 24 134 18 0 44 244 18 0 68 378 Death 2 2 3 134 1 2 3 244 1 6 6 378 Ml 1 5 2 134 1 6 4 244 1 6 6 378 Q wave MI 0 7 1 134 0 0 0 244 0 3 1 378 Non Q wave MI 0 7 1 134 1 6 4 244 1 3 5 378 TVR 14 9 20 134 16 0 39 244 15 6 59 378 TVPTCA 12 7 17 134 7 8 19 244 9 5 36 378 TV CABG 2 2 3 134 8 6 21 244 6 3 24 378 12 e Novoste D03745 Rev D 03 08 ETA CATHP Pullback versus Non pullback 60 mm Major Adverse Events In and Out of Hospital to 6 months All Patients N 139 Combined In and Out Pullback Non pullback Combined Of Hospital Events to 6 Months N 109 N 30 N 139 MACE 19 0 20 105 13 8 4 29 17 9 24 134 Death 2 9 3 105 0 0 0 29 2 2 3 134 Ml 0 0 0 105 6 9 2 29 1 5 2 134 Q wave MI 0 0 0 105 3 4 1 29 0 7 1 134 Non G wave MI 0 0 0 105 3 426 1 29 0 7 1 134 TVR 16 2 17 105 10 3 3 29 14 9 20 134 TVPTCA 13 3 14 105 10 3 3 29 12 7 17 134 TV CABG 2 9 3 105 0 0 0 29 2 2 3 134 The following adverse events were NOT observed during Additional potential Adverse Events associated with the the clinical investigations but are recognized as potential radiation portion of vascular brachytherapy include but adverse events associated with the non radioactive portion ore not limited to of vascular brachytherapy including but not limited to Radiation Induced Malignancy
16. 18 mrem 0 18 mSv 40 mm Beta Cath 3 5F System Hand Dose 5 mrem 0 05 mSv AO mm Beta Cath 3 5F System Skin Dose Equivalent 24 mrem 0 24 60 mm Beta Cath 3 5F System Hand Dose 8 mrem 0 08 mSv 60 mm Beta Cath 3 5F System Skin Dose Equivalent 36 mrem 0 36 5 Annual Hand and Skin Dose Limit for Occupational Workers 50 000 mrem 500 The estimated dose from the 30 mm Beta Cath 3 5F System is 0 04 of the annual dose limit the estimated dose from the 40 mm Beta Cath 3 5F System is 0 05 of the annual dose limit and the estimated dose from the 60 mm Beta Cath 3 5F System is 0 07 of the annual dose limit Skin dose is defined here as the dose received to the unprotected hand only not the whole body dose Clinician Hand Dose during Pre and Post Treatment Activities with B Cath 3 5F XL Delivery Catheter Sei 2 minutes for device preparation amp 2 minutes or post treatment activities 30 mm Beta Cath System Hand Dose 4 mrem 0 04 30 mm Beta Cath System Skin Dose Equivalent 50 mrem 0 50 mSv 40 mm Beta Cath System Hand Dose 5 mrem 0 05 mSy AO mm Beta Cath System Skin Dose Equivalent 67 mrem 0 67 mSy 60 mm Beta Cath System Hand Dose 8 mrem 0 08 mSv 60 mm Beta Cath System Skin Dose Equivalent 100 mrem 1 0 mSv The estimated dose from the 30 mm Beta Cath System is 0 1 of the annual dose limit the estimated dose f
17. 38 58 25 33 18 In Hospital MACE 2 3 11 7 6 2 0 20 9 41 0 0050 3 131 11 94 14 225 0 06 0 68 17 35 1 48 Out of Hospital 16 4 61 7 35 1 0 27 45 28 lt 0001 MACE to months 22 134 58 94 80 228 0 18 0 40 57 90 32 66 CORE LAB SUBSET ANALYSIS In Analysis Segment 0 15 0 71 0 85 0 57 0 59 0 71 N A 0 70 lt 0001 Late Loss at 6 months 49 81 130 0 92 0 48 Stent Segment Late 0 11 0 90 1 00 0 66 0 67 0 87 N A 0 89 lt 0001 Loss at 6 months 49 80 129 1 16 0 61 In Analyisis Segment Late Loss Index at 6 1 34 7 32 1 37 4 78 0 34 6 00 N A 2 71 0 0240 Months 49 80 129 4 82 0 60 Stent Segment Late Loss Index at 6 0 01 0 60 0 86 0 61 0 54 0 73 N A 0 85 lt 0001 Months 49 79 128 1 07 0 63 In Analysis Segment Binary Restenosis 28 6 76 5 58 5 0 37 47 97 lt 0001 Rate at 6 Months 14 49 62 81 76 130 0 24 0 59 65 41 30 54 Stent Segment Binary Restenosis Rate 20 4 70 0 51 2 0 29 49 59 lt 0001 at 6 Months 10 49 56 80 66 129 0 16 0 52 66 47 32 71 Numbers are counts n or Mean SD Cl Confidence Interval Relative Risk p1 p2 SE sqrt 1 1 p2 n2p2 Cl RR exp 1 96 SE Difference p_ p_ SE sqrt 1 p1 n1 1 p2 1 p2 n2 1 Cl diff 1 96 SE 0 5 1 n1 1 n2 NA Not applicable Procedure Success Attainment of a lt 50 residual di
18. 7 188 1 1 0 40 2 93 0 3 3 5 4 2 0 8720 Numbers are counts sample size or Mean SD Cl Confidence Interval N A Not applicable Relative Risk S 90 Placebo SE sqri 1 p1 n3 1 1 2 21 Cl RR exp 1 96 SE Difference Sr 90 Placebo SE sqri p1 q1 n1 p2 q2 n2 Diffx1 96 SE Target Lesion Success Attainment of a final residual stenosis of lt 50 by QCA using any percutaneous method If QCA was not available the visual estimate of diameter stenosis was used Procedure Success Attainment of a final residual stenosis of lt 50 by QCA using any percutaneous method and no in hospital major adverse cardiac events MACE If QCA was not available the visual estimate of diameter stenosis was used Device Success Successful delivery of the Beta Cath System Stent segment was defined as the area confined to the proximal and distal borders of the stent Analysis segment was defined as the segment that extends 5 mm proximal and distal to the radiated or injured landmark whichever was longest in length Survival estimates from Kaplan Meier method Standard error estimate from Peto formula TLR free Freedom from target lesion revascularization TVR free Freedom from target vessel revascularization TVF free Freedom from death MI and target vessel revascularization MACE free Freedom from death MI emergent CABG and target vessel revascularization In Hospital MACE Death Q wave or
19. BCS 9 Number of cases reporting initial device malfunctions with subsequent treatment success lO Number of minor malfunctions not affecting Ability to Treat 89 Number of Cases Resulting In Use of the Temporary Storage Container included in the Device Malfunctions category listed above 6 Patients Unsuccessfully Treated and Involving Use of the Temporary Storage Contdiner 2 02 2 25683 44 ere Bail Out is defined as physician use of the Novoste Temporary Storage Container a3 Novoste D03745 Rev D 03 08 Major Adverse Events In Hos ETA CATH Additionally the original Beta Cath 5F System was evaluated in the START 40 20 Trial a multi center registry involving 207 patients The START 40 20 Trial studied the treatment of lesions treatable with a 20 mm balloon with a AO mm Source Train The observed adverse events are summarized in the following tables ital and Out of Hos Patients Treated N 439 START 40 20 versus START Placebo START 40 20 N 207 Patients Combined In and Out of Hospital Complications to 240 Days START Placebo N 232 Patients All Patients N 439 Patients pital to 240 days Difference 95 C I Any MACE Death MI Emergent CABG TVR 19 3 40 207 25 9 60 232 22 8 100 439 6 5 14 3 1 3 Death 2 4 5 207 0 4 1 232 1 4 6 439 2 0 0 3
20. Catheter Tip Indicator of Source Train Radiopaque 30 mm 40 mm and 60 mm Radiation Train Length Markings Guidewire Exit Port 1 cm from distal tip of the Delivery Catheter Maximum Guidewire 0 014 0 36 mm Minimum Guiding Catheter 6F 1 7 mm 0 067 ID TRANSFER DEVICE Size 22 2 cm x 8 9 cm x 7 0 cm length x width x height Weight 0 68 kg Operating Environmental Conditions Temperature 18 C to 27 C Relative Humidity 45 85 Pressure 550 mmHg to 795 mmHg Battery Power Source 6 0 Volt Lithium lon Commercially available camera battery e g Duracell DL223A Sanyo CRP2 or compatible SEALED SOURCES Isotope Strontium 2 5 mm x 0 38 mm length x diameter Sealed Source Size Stainless Steel 304 0 42 mm ID 0 47 mm OD Source Train Jacket 30 mm Source Train 2 Radiopaque markers 12 Radioactive Sources 40 mm Source Train 2 Radiopaque markers 16 Radioactive Sources 60 mm Source Train 2 Radiopaque markers 24 Radioactive Sources Strontium Half life 28 8 years Dose Rate and Activity Activity and absorbed dose rate to water at 2mm from the Source Train is determined wit a NIST traceable Source Train by Best Vascular and pro vided on the Best Vascular Calibration Certificate Note Do not ship the Transfer Device unless a Leak Test has been performed within the previous 6 months Follow the radiation safety and handling instructions in this User s Manual Test the
21. D Section D Page 40 Section E Page 40 41 Placement of the Delivery Catheter CARD Section F Page 41 ACTIVE Transfer Device Prep Prime IST Removal RO D CARD Sections H amp J Pages 42 44 Section G Page 42 Send Return of ACTIVE Radiation Source Train IRO DJ Sections K amp L Pages 44 46 Delivery Catheter Removal CARD Section M Page 46 Disassembly of the Beta Cath 3 5F System MP RSO D Section N Page 46 Post Procedural Radiation Checks MP RSO D Section O Page 46 amp 47 Drying and Storing of the Transfer Devices RO MP RSO D Section P Page 47 m e Novoste D03745 Rev D 03 08 ETA CATHP A Active Device Receipt RO MP RSO D Note The following section describes procedures recom mended by Best Vascular which unless superseded by local regulation or institutional policy or procedure should be followed by the user The Radiation Safety Personnel are responsible for ensuring the safe handling of radioactive materials at all times It is incumbent upon these individuals to be thoroughly familiar with all han dling procedures described herein and to augment them to comply with local regulations and institutional proce dures if necessary It is beyond the scope of this manual lo provide a comprehensive review or adequate disserta tion on health physics This manual should be used as a guide to the health professional in the i uad for the safe h
22. Delivery Catheter and guidewire from patient e Place the Delivery Catheter and active Transfer Device still attached into the Temporary Storage Container Close the Temporary Storage Container WARNING Avoid direct contact with unshielded radiation sources in the Delivery Catheter as unin tended radiation exposure will occur WARNING Do not grasp catheter directly with hands or cut the catheter as unintended radiation exposure may result After the entire system has been placed into the Temporary Storage Container obtain the Radiation Survey Meter If the Survey Meter has a sliding beta shield on the detector open the shield to increase the sensitivity to beta radiation Survey the patient and sur rounding area If the background radiation coming from the Temporary Storage Container prevents a good Survey move the Temporary Storage Container to a secure location If increased room levels of radiation are found that were not measured in the background Survey made before the procedure Source s may be out of the Temporary Storage Container Without raising the lid on the Container look through the transparent sides of the Container to attempt to locate the missing jacketed Source Train If the jacketed Source Train can be located in the Catheter or acrive Transfer Device in the Temporary Storage Container place the Temporary Storage Container in a shielded secure location and call
23. Essential Prescribing Information Special Considerations As with other vascular brachytherapy procedures safety Vessel or lesion morphologies that would preclude and effectiveness has not been demonstrated in the fol revascularization or placement of the Rail V lowing populations 3 5F Delivery Catheter Patients undergoing or having prior chest radiotherapy Patients presenting with Patients unable to tolerate the recommended dwell time thrombotic lesions of the Source Train in the Delivery Catheter 3 5 Fr I multiple vessel lesions vein groft segments The safety and effectiveness of the Beta Cath 3 5F overlapping stents System have not been evaluated in reference vessel myocardial infarction less than or equal to 72 diameters 2 7 mm hours prior to the procedure and or os uM ejection fractions less than 3076 Patients requiring revascularization methods other than balloon angioplasty directional and rotational atherec Patients who have received a heart transplant tomy and excimer laser for revascularization of in stent restenosis Women of child bearing potential who are pregnant or suspect pregnancy Adverse Events The original Beta Cath 5F System was evaluated in the Stents And Radiation Therapy START Trial a multicenter randomized placebo controlled trial involving 476 patients The START Trial primarily studied the treatment of lesions treat able with a 20 mm Ball
24. Green Arrow Indicator light is illuminated When the Source Train has been moved out of the proper position within Source Chamber of the Transfer Device the Amber Arrow Indicator light is illuminated Novoste The Fluid Control Lever allows for the sending and return of the Source Train from the Transfer Device This action can only take place when the Transfer Device is properly connected to the Delivery Catheter the Proprietary Connector is fully locked and the blue line is visible on the Proprietary Connector Lock Latch Exchange of Battery Power Source Novoste Transfer Devices are designed to allow for easy exchange of the product s power supply A Volt Lithium ion battery powers the Transfer Device Included in the Transfer Device packaging is a 6 Volt Lithium ion battery To insert or replace the battery open the battery door and insert the battery To open the battery door simply use a screwdriver or other appropriate hand tool to turn the battery door screw located on the back of the Transfer Device As the screw releases the battery door will open on its hinge exposing the battery compartment Place the new battery inside the compartment with its contacts facing downward Once inserted close the battery door and tighten the screw by turning it to the right until it is firmly set Test the Transfer Device power supply by pressing the ON OFF button as it is now ready for use For battery disposal follow battery ma
25. Section F Placement of Delivery Catheter PRECAUTION If resistance is felt and believed to be due to the Delivery Catheter remove the entire Delivery Catheter including IST from the patient and prepare another Delivery Catheter for use begining with Section E Delivery Catheter Inspection Preparation Co Prior to IST removal have a non sterile assistant put on sterile gloves and perform the following PRECAUTION Upon removal from the Delivery Catheter the IST is non sterile Carefully handle the non sterile IST to ensure no contamination of field sterility Grasp the non sterile IST and carefully remove the non sterile IST from the Delivery Catheter while the position of the Delivery Catheter is main tained under fluoroscopy Discard the non sterile IST and gloves Delivery Catheter Transfer Device Reattachment 1 Bring the prepared ACTIVE Transfer Device to the posi tioned Delivery Catheter 2 Insert the Proprietary Connector of the Delivery Catheter through the distal hole of the Sterile Bag into the Proprietary Connector Receptacle of the ACTIVE Transfer Device Rotate the Proprietary Connector to ensure a secure connection 3 Lock the Proprietary Connector to the ACTVE Transfer Device by fully depressing the Proprietary Connector Lock Latch until a blue line is visible PRECAUTION Do not force the connector lock latch into positi
26. Serial Number Part Number Minimum Required i Guiding Catheter Inner Diameter T Radioactive ACTIVE Source Train Non Active Source Train jor SS Locked Unlocked Gate Switch Lock Position Indicator Fluid Lever ON Power ON OFF Button Low Battery Indicator lt 2 SEND RETURN RETURN Adequate Pressure to Hold Sources at Treatment TX Area Amber light illuminated a3 Novoste Symbols and Graphics Used with the Beta Cath 3 5F System Adequate Pressure to Send Return Sources Amber light illuminated v4 A Excessive Pressure Red light illuminated Source Train OUT of the CHAMBER Source Train IN the CHAMBER Gate OPEN Gate CLOSE MFR Symbol DO NOT USE DAMAGED PKG DO NOT USE OPEN PKG ETA CATH Attachment B Additional Dosimetry Information for the Beta Cath 3 5F System Estimated Doses to Patient Non Target Tissues and Clinicians in a Typical Procedure The following are the estimated doses to the Cardiologist Radiation Oncologist Cath Lab Staff and Patient from flu oroscopy during PTCA and from the Beta Cath 3 5F System Clinician Hand Dose during Pre and Post Treatment Activities with the B Rail 3 5F Delivery Catheter p 2 minutes for device preparation amp 2 minutes or post treatment activities 30 mm Beta Cath 3 5F System Hand Dose 4 mrem 0 04 mSv 30 mm Beta Cath 3 5F System Skin Dose Equivalent
27. Transfer Device for leakage at intervals not to exceed 6 months Use a Leak Test method capable of detecting 185 Bq 005 uCi of Sr Y 90 redai withdraw a leaking device from use and store it for disposal and or return to Best Vascular Inc File a report of any leaking device with the authority and notify Best Vascular Inc Retain Leak Test records Vil STORAGE AND TRANSPORT Store Delivery Catheters Procedure Accessory Packs Transfer Devices and Transport Case in a cool dry place and protect from sunlight Store the Transfer Device and Transport Case in an area designed by your institution al policies and or procedures for radioactive materials qe Novoste 53 D03745 Rev D 03 08 Attachment ETA CATH in the manual or on the products Attention See Accompanying Documents A A IPX1 Type CF Equipment Equipment or Parts of Equipment Intended for Direct Cardiac Contact Radioactive Radiation Warning Symbol Equipment Protected Against Dripping Water Use Before Date Date of Manufacture Single Use Only Do Not Reuse B Storage Shipping Temperatures S12 Protect from Z lt Direct Sunlight 4 4 4 544 F Store in a Dry Place Sterile Product Sterilized by STERILE EO Ethylene Oxide Gas Non Sterile Product NON STERILE beta p Lot Number LOT Catalog Number or Reorder Number 54 D03745 Rev D 03 08 SN
28. and injury may result Required equipment is provided for this purpose in the Response Kit 4 Novoste ETA CATH III Essential Prescribing Information e Should breach of ACTIVE Source Train containment occur 1 Notify personnel present of missing source s 2 Follow institutional procedures regarding personnel allowed to enter or leave the room until the source is contained 3 Individuals involved in source recovery should wear disposable gloves an extremity dosimeter on the hand expected to receive the highest dose and a whole body dosime ter on the front of the body between the neck and the waist PRECAUTIONS The Beta Cath 3 5F System is designed to be used by a team of appropriately trained personnel At a minimum this team should include a Cardiologist Radiation Oncologist and Medical Physicist Beta Cath 3 5F System Preparation Prior to any procedure the equipment should be thoroughly examined to verify the proper function and integrity of the system Handle the Transfer Device carefully and do not use if dropped Do not use the Transfer Device if the controls and indicators are not functioning correctly or the LED light test is not observed Do not begin a pro cedure if the Low Battery light is blinking If the Low Battery Indicator starts blinking during a procedure there will be enough battery power to complete the procedure The Transfer Device is not
29. are required to complete the procedure e Transport Case which contains an Transfer Device and Response Kit Delivery Catheter and Procedure Accessory Pack Sterile Water for Irrigation Temporary Storage Container Portable Survey Meter for beta and bremsstrahlung Sterile Cover ior Survey Meter Institutional Radiation Procedural Record 1 Obtain the Transfer Device stored in the locked Transport Case 2 Conduct a Radiation Survey of LACTIVE Transfer Device and note results for future reference as ACTIVE Transfer Device baseline reading If at any time a Survey Meter reading of the Transfer Device is significantly different from the initial baseline read ing stop all activity and re survey the Transfer Device making sure the fluoroscopy is off If the reading is not within the acceptable baseline range then refer to Section Q Emergency Source Recovery Procedure 3 Inventory the Source Train and radiopaque markers within the Transfer Device and record results 4 Return the Transfer Device to the White Lead Lined Storage Container until trained authorized person nel request the device for the procedure 5 Survey the procedure room and note results Fluoroscopy MUST be off during the radiation sur veys 6 Survey the Delivery Catheter before opening the packaging and note results as initial Delivery Catheter background reading If at any time a Survey Meter reading of the Delivery Ca
30. are two arrow indicator lights Green and Amber adjacent to the Source Chamber viewing window After the LED light test is completed either the Green or Amber Arrow Indicator light will remain illuminated depending on the position of the Source Train When the Source Train is correctly positioned in the Transfer Device a Green Arrow Indicator light will illuminate After the Source Train has been moved out of proper position in the Transfer Device an Amber Arrow Indicator light will illuminate The Gate Control Switch is a sliding switch which opens or closes the Gate to the Source Chamber allowing the Source Train to enter or exit the Source Chamber To the Gate slide the switch completely forward until the Blue Arrow aligns wit The clear window allows for magnified visual inspection of the Source Train a3 Novoste D03745 Rev D 03 08 ETA CATH Table 8 Transfer Device Controls and Indicators Continued Fluid Control Lever Fluid Pressure Indicator Lights below First TX Amber Pressure Indicator Lights Second 44 Amber Pressure Indicator Lights Third 144 Amber Pressure Indicator Lights Fourth N Red Pressure Indicator Light Use Period 34 D03745 Rev D 03 08 This two position lever controls the fluid flow and direction of Source Train movement will allow fluid to hydraulically transport the Source Train into the Delivery Catheter will allow fluid to hydraulically transport the S
31. avoid contamination of field sterility PRECAUTION After performing the IST Reinsertion procedure do not attempt to reinsert the IST a second time into the Delivery Catheter since the IST will no longer be sterile The following materials are recommended in order to complete the IST reinsertion procedure Sterile gauze pad non absorbent backed Sterile gauze sponges 4 in x 4 in 10 2 cm x 10 2 cm 6 Once the IST is reinserted into the Delivery Catheter discard the gauze pad and sponges 7 Move the Delivery Catheter with loaded IST to the patient and place the Delivery Catheter across the interventional injury site per Section F Placement of the Delivery Catheter IST Removal 1 Once the Delivery Catheter has been positioned with the IST across the interventional injury site close the hemostatic valve 2 Grasp the proximal end of the IST and gently with draw the IST far enough into the guiding catheter to approximately the projection of the aortic arch and readvance it at least twice to find any potential obsta cle for the ACTIVE Source Train e Novoste 49 D03745 Rev D 03 08 ETA CATH PRECAUTION If resistance is felt and believed to be due to patient anatomy withdraw the entire Delivery Catheter including IST and optimize guiding catheter selection and or perform a re intervention at the target lesion Reposition the Delivery Catheter including IST per
32. comparatively little dose a3 Novoste D03745 Rev D 03 08 Attachment B Additional Dosimetry Information for the Beta Cath 3 5F System Figure 11 Relative Dose Rate from Source Train as a Function of Distance in Water 03 l l l Relative Dose Rate Relative Dose Rate 0 0 2 0 4 0 6 0 8 1 1 2 1 4 1 6 Distance From Source Centerline cm Note This graph represents model of dose a function of distance from the source in water The graph is not ee for ose planning Refer to the Calibration Certificate for the recommended dose prescription and treatment time calculation Additionally tabular values of the depth dose normalized to 100 at the reference point of 2mm from the centerline of the source train in water are provided below The data provides the dose rate at the distance of interest relative to the reference dose rate at 2mm from the centerline of the source train in water Distance from Source Relative Centerline mm Dose 0 75 370 1 00 261 1 25 196 1 50 155 1 75 121 2 00 100 2 25 81 3 2 50 67 1 2 75 53 8 3 00 45 6 3 25 38 5 3 50 31 6 3 75 25 8 4 00 20 9 4 25 17 4 4 50 14 2 4 75 5 00 5 25 5 50 5 75 6 00 6 25 6 50 5 Novoste 57 D03745Rev D 03 08 Attachment B Additional Dosimetry Information for the Beta Cath 3 5F System The following graphs provide doses along the centerline of 30mm 40mm and 60mm Source Trains at various radial distances in water D
33. distal tip that facilitates place ment of the Delivery Catheter through the Guiding Catheter 30 D03745 Rev D 03 08 e A proximal end that consists of a Proprietary Connector which utilizes squeeze tabs to ensure a secure connection between the Delivery Catheter and the Transfer Device Working length of 135 cm Overall length of 180 cm BRail 3 5F Delivery Catheter 267 cm BRail 3 5F XL Delivery Catheter e Sterile package includes one B Rail 3 5F Delivery Catheter pre loaded IST and a Flushing Cannula Procedure Accessory Pack included inside the BRail 3 5F Delivery Catheter Box The Procedure Accessory Pack contains the disposable single use sterile accessories required to perform the procedure The pack contains one 1 Fluid Collection Bag two 2 20 ml Three Ring Syringes two 2 Extension Connectors one 1 Sterile Bag one 1 Proprietary Connector Cover o f k a a Pi E Novaste ETA CATHP Transfer Device Controls amp Indicators The Transfer Device serves the following functions 1 Stores the Source Train 2 Aligns and connects the Delivery Catheter with the Transfer Device 3 Controls the direction of fluid flow allowing delivery and return of the Source Train 4 Shields beta radiation Note The color lights or graphics associated with the Transfer Device are designed to convey the following Blue Informational features of the Trans
34. in the Transfer Device Do not use saline as a hydraulic fluid in the Transfer Device corrosion may occur Note To use the optional Fluid Management System open a Merit Medical 3 Way Stopcock 200 psi mini mum and Merit Medical High Pressure 200 psi mini mum Injection Line Merit Medical Systems Inc onto sterile field Figure 10 Or Best Vascular qualified equivalent 2 Fill two 20 ml syringes with Sterile Water for Irrigation Attach an Extension Connector to each of the 20 ml Syringes Place the syringes on the prep table 3 Flush the Delivery Catheter guidewire lumen by inserting the blunt Flushing Cannula into distal tip of catheter and flush with 1 ml heparinized saline 4 Examine the Delivery Catheter prior to use for bends kinks or other signs of damage Ag s Rev D 03 08 el Novaste ETA CATH PRECAUTION Do not use the Delivery Catheter if there is evidence of damage Damaged catheters may cause vessel trauma or unpredictable results during Use 5 Visually confirm that the Indicator of Source Train IST is inserted into and seated against the internal distal marker stop at the end of the Delivery Catheter 6 Attach one of the two 20 ml syringes filled with Sterile Water for Irrigation to the IST hub and flush the inner lumen of the Delivery Catheter with 2 3 ml of Sterile Water for Irrigation while observing the tip of the Delivery Catheter for any evidence of fluid
35. is in position Pull to withdraw approximately 1 ml Sterile Water for Irrigation and push to apply for ward pressure to the syringe plunger to reposition the non active Source Train b In the event that the non active Source Train still cannot be confirmed to have reached the injury site immediately perform the following maneuver to return the non active Source Train to the NON ACTIVE Transfer Device e Move the Fluid Control Lever to Depress syringe and apply continuous positive pressure so that all three Amber Pressure Indicator lights are illuminated during the return of the NowAcrive Source Train An audible click will be heard as Non active Source Train returns to the Source Chamber Maintain Pressure on the syringe while visually confirming that the entire NoN active Source Train is located within the Source Chamber and that the Green Arrow Indicator light is ON Note Once the Non active Source Train is locat ed within the Source Chamber of the Transfer Device the Delivery Catheter can be removed and the proce dure restarted with a new Delivery Catheter following standard Test and Placement procedures c In the event the non active Source Train has not reached the injury site or been returned to the Device perform the following Loosen the he
36. non sterile storage case It will be shipped to the hospital without radioactive material only os a storage case i e Type A container for the Clow items Single Transport Case Combination Lock to help secure from unauthorized access A Response Kit shipped inside Transport Case Battery operated flashlight Tweezers Source Recovery Probe Source Container with a screw on top intended for single use Magnifying Glass Compartment to store the White Lead Lined Storage Container containing the ACTIVE Transfer Device An empty storage compartment qa Novoste The Transport Case with an Transfer Device should only be stored in a secure area designated for radioactive material storage The Twin Transport case is provided to those hospitals which possess two LACTE Transfer Devices It contains the same items as the single Transport Case but has an additional compartment to store a second White Lead Lined Storage Container containing the second LACTIVE Transfer Device Twin Transport Case Temporary Storage Container The Temporary Storage Container is a clear plastic non sterile container This Container is designed to shield beta radiation and is used to temporarily store the Beta Cath 3 5F System in the event that the ACTIVE Source Train is unable to be returned to the Source Chamber of the Transfer Device 29 D037
37. of appropriately trained personnel At a minimum this team should include a Cardiologist Radiation Oncologist and Medical Physicist Detailed Device Description The Beta Cath 3 5F System is designed to provide pro tection to health care workers and to minimize patient exposure to ionizing radiation The unique design of the Transfer Device allows the beta sources to be contained and shielded during transport and storage without substan tially modifying the safety procedures and protocols cur rently used in Cardiac Catheterization Labs The Beta Cath 3 5F System consists of four components the two major components are described below 1 The Transfer Device is a multiple use hand held device used to store the Source Train and to deliver the sources to and from the vessel by means of the Delivery Catheter The Transfer Device is designed to shield health care workers from beta radiation The single use Delivery Catheter does not allow the Sources to come in contact with the patient s blood or tissue The Transfer Device will contain either an or NON ACTVE Source Train The 3 5F System compatible Transfer Device is color coded gray The Source Train will contain a wire jacketed train of 12 30 mm Source Train 16 40 mm Source Train or 24 60 mm Source Train miniature cylindrical radioactive sealed sources containing Strontium Yttrium Sr Y pure beta emitters and two one dis tal and one proxim
38. your Best Vascular Representative to assist with transferring the jacketed Source Train back to the Transfer Device If any portion of the jacketed Source Train cannot be the Temporary Storage Container proceed with the next step to locate the missing Source s WARNING Never cut the Delivery Catheter Cutting the Delivery Catheter may result in dam age to the active Source Train compromise con tainment of the sealed radioactive material and may result in unnecessary contamination and radiation exposure of the patient workers equip ment facilities and or the public environment 4 If the jacketed ACTIVE Source Train is damaged allowing individual Sources to be released a thorough Radiation Survey using a Radiation Survey Meter should be performed Survey the room careful ly until a radiation increase is detected Keep in mind other possible sources of radiation such as fluoro scope other sealed sources or even sources in adjoining rooms Compare the levels of radiation from other sources to those noted in the Survey per formed before the procedure 5 When increased radiation is located using the Radiation Survey Meter use the Response Kit which contains a magnifying glass and flashlight to assist in locating the active Source s The Active Source s can be shielded by placing objects such as a piece of plastic or book over the activ
39. 03 08 Five 5 patients who received radiation died during the START 40 20 trial The deaths occurred between 17 and 200 days Two 2 patients died of cardiac deaths related to the target lesion one following non GMI heart failure complicating the index procedure and one of mas sive Gl bleed ischemic bowel complicating reinterven tion with Reopro Eli Lilly and Company of the target lesion The remaining three died of cardiac death not related to the target lesions or the device one patient died from CHF and multi system failure following a non target lesion intervention one patient died from compli cations surrounding an intracerebral bleed and one patient died following aortic valve replacement and non target vessel CABG There were 207 patients treated with the Beta Cath 5F System BCS in the Stents and Radiation Therapy 40 20 Trial Device success defined as successful deliv ery and treatment with the BCS was achieved in 200 of the 207 patients 97 Summary of Device Malfunctions of Patients Number of patients enrolled in START 40 20 Trial 207 Number of Cases with unsuccessful delivery and treatment with the BCS 7 Number of cases reporting initial device malfunctions with subsequent treatment success 3 Number of Cases Resulting In Use of the Temporary Storage Container included in the Device Malfunctions category listed above 8 Patients Unsuccessfully Treated and
40. 1 1 0 73 1 58 1 3 5 9 8 5 0 7257 Aneurysmt 0 7 1 150 0 5 1 198 1 3 0 08 20 93 0 2 1 5 1 8 0 8434 Stent Thrombosis to 30 days 0 0 0 207 0 0 0 244 EJ 0 0 Site Thrombosis Days 31 240 1 0 2 207 0 0 0 244 ES 1 0 0 4 2 3 0 1238 Total Occlusions Angiographic 3 3 5 150 4 0 8 198 0 8 0 28 2 47 0 7 4 7 3 3 0 7305 Numbers are counts sample size or Mean SD Cl Confidence Interval Relative Risk START 40 20 Sr 90 START Sr90 SE sqri 1 p1 n11 1 p2 n21 Cl RR exp 1 96 SE Difference START 40 20 Sr 90 START Sr 90 SE sqrt p q1 n1 p2 q2 n2 Diff 1 96 SE N A Not applicable Target Lesion Success Attainment of a final residual stenosis of lt 50 by QCA using any percutaneous method If QCA was not available the visual estimate of diameter stenosis was used Procedure Success Attainment of a final residual stenosis of lt 50 by QCA using any percutaneous method and no in hospital major adverse cardiac events MACE If QCA was not available the visual estimate of diame ter stenosis was used Device Success Successful delivery of the Beta Cath System Footnotes are continued on the following page Stent segment was defined as the area confined to the proximal and distal borders of the stent Analysis segment was defined as the segment that extends 5 mm proximal and distal to the radiated or injured landmark whichever was
41. 1 8 2 1 2 2 2 4 2 7 3 0 START Placebo Entered 232 230 216 209 198 185 175 166 156 Lost to Follow up 0 8 2 2 0 0 4 7 31 Incomplete 0 0 0 0 0 0 0 0 0 At risk 232 0 226 0 215 0 208 0 198 0 185 0 173 0 162 5 140 5 Events 2 5 9 13 10 5 3 Z Events Month 5 9 13 10 5 3 7 Survived 99 1 96 5 94 3 90 2 84 3 79 7 77 4 76 0 72 2 SE 0 6 1 2 1 6 2 0 2 5 2 7 2 9 3 0 3 5 Test Between Groups Test Chi Square Deg Frdm P Value Wilcoxon 3 66 1 0 0559 Log Rank 3 57 1 0 0590 a Novoste 20 D03745Rev D 03 08 ETA CATHD RENO Long Sub Analysis The European Surveillance REgistry with the NOvoste Beta Cath System RENO Long Subgroup a sub analysis of 139 of the 1098 patients treated with the Beta Cath 5F System in the RENO Registry a prospective commercial registry at 46 centers in Europe began June 1 1999 The RENO Long sub group focused on patients with diffuse in stent restenotic lesions in single vessels treated by longer than 40 mm of radiation source train Treatments with the Beta Cath 5F System included stepping pullback procedures uti lizing 30 40 or 60 mm source trains or a single 60 mm source train The acute and follow up 6 month for RENO Long and WRIST Long WRIST and 8 month for START clinical and angiographic results demonstrated that the procedural success rate defined as the attain ment of a residual stenosis lt 30 diameter stenosis at the time of intervention with succ
42. 167 in the START Sr 90 arm and 56 3 89 158 in START 40 20 p 0 2664 The TVR rate was 43 1 72 167 in the Sr 90 arm and 16 5 26 158 in START 40 20 p 0 0000 One new aneurysm was reported at the 3 year follow up in the START 40 20 group Summary of 4 year Follow Up START Sr 90 vs START Placebo The 4 year MACE rate was 54 2 90 166 in the Sr 90 arm and 64 7 99 153 in the Placebo arm p 0 0680 The TVR rate was 45 2 75 166 in the START Sr 90 arm and 57 5 88 153 in the Placebo arm p 0 0332 No new aneurysms were reported at the 4 year follow up for either group START Sr 90 vs START 40 20 The 4 year MACE rate was 54 2 90 166 in the START Sr 90 arm and 57 8 89 154 in START 40 20 p 0 5734 The TVR rate was 45 2 75 166 in the START Sr 90 arm and 16 9 26 154 in START 40 20 p 0 0000 No new aneurysms were reported at the 4 year follow up for either group ab Novoste in the START Sr 90 arm and 66 9 95 142 in START 40 20 p 0 4673 The TVR rate was 51 0 79 155 in the START Sr 90 arm and 19 27 142 in START 40 20 p 0 0000 No new aneurysms were reported at the 5 year follow up for either group Conclusions START Trial START Sr 90 vs START Placebo Results of patients treated in the START Trial through 5 years demonstrated continued significance in favor of the Sr 90 group for MACE through 3 years with the 4 year rate nearly demonstrating significance at a level of p 0 06 While st
43. 3 3 02 PostProcedure Stent Segment Percent Diameter Stenosis DS Meanz SD 23 8 15 7 196 22 9 13 5 243 0 8 1 9 3 6 0 5479 Range min 13 4 66 0 31 1 53 2 PostProcedure Analysis Segment Percent Diameter Stenosis DS Meanz SD N 33 2 14 2 196 31 4 10 2 243 1 8 0 5 4 1 0 1329 Range min 3 1 74 0 6 7 57 6 Follow Up Stent Segment Minimal Lumen Diameter MLD in mm Meanz SD 1 85 0 65 149 1 96 0 66 197 0 11 0 25 0 03 0 1088 Range min max 0 00 3 41 0 00 3 45 Follow Up Analysis Segment Minimal Lumen Diameter MLD in mm SD 1 60 0 58 150 65 0 64 198 0 05 18 0 08 0 4252 Range min 0 00 3 16 0 00 3 18 Follow Up Stent Segment Percent Diameter Stenosis DS SD 30 7 23 1 149 30 4 22 7 197 0 3 4 6 5 2 0 8991 8 0 100 0 32 2 100 0 Follow Up Analysis Segment Percent Diameter Stenosis DS SD 40 2 20 1 150 41 7x 20 7 198 1 5 5 8 2 9 0 5046 Ronge 2 4 100 0 10 4 100 0 Safety Measures and Other Clinical Events to 240 days In Hospital MACE 1 9 4 207 2 5 6 244 0 8 0 22 275 0 5 3 2 22 0 7051 OutofHospital MACE to 240 Days 17 9 37 207 16 0 39 244 1 1 0 74 1 68 1 9 5 1 8 8 0 5930 In and Out ofHospital MACE to 240 Days 19 3 40 207 18 0 44 244
44. 3 37 0 61 28 96 1 30 54 90 Stent Segment Binary Restenosis Rate 27 0 0 0 20 4 10 49 7 18 27 03 0 0926 at 6 Months 10 37 0 12 0 45 114 22 7 00 47 05 Numbers are counts n or Mean SD n Cl Confidence Interval Relative Risk p1 p2 SE sqrt 1 p1 n1 1 p2 n2p2 Cl RR exp x1 96 SE Difference p1 p5 SE sqrt p1 1 p1 In1 1 p2 1 p2 n2 1 Cl diff 1 96 SE 0 5 1 1 n2 NA Not applicable Procedure Success Attainment of a lt 50 residual diameter stenosis using any percutaneous method and no in hospital MACE Brachytherapy Success Attainment of a lt 50 residual stenosis and successful delivery of the radiation device Restenosis was defined at 25076 in stent diameter stenosis at the follow up angiogram If an in stent measurement was not available the In lesion diameter was used In Analysis Segment Stent Probe Edges areas Survival Estimates from Kaplan Meier estimate Standard Error estimate by Peto formula TIr Free No Target Lesion Revascularization Mace Free No Death Q Wave of Non Q Wave Mi or Target Vessel Revascularization The Beta Cath System is not indicated for pullback stepping gi Novoste 27 D03745 Rev D 03 08 ETA CATH IV Instructions For Use The following section provides instructions for using the Beta Cath 3 5F System from Best Vascular Inc The Beta Cath 3 5F System is designed to be used by a team
45. 4 2 Myocardial Infarction Q or Non Q 4 3 9 207 3 0 7 232 3 6 16 439 1 3 2 2 4 9 Q Wave MI 1 4 3 207 0 0 0 232 0 7 3 439 1 4 0 2 3 1 Non Q Wave 2 9 6 207 3 0 7 232 3 0 13 439 0 1 3 3 3 1 Emergent CABG 0 0 0 207 0 0 0 232 0 0 0 439 0 0 Target Lesion Revascularization 11 1 23 207 22 4 52 232 17 1 75 439 11 3 18 2 4 4 TLCABG 6 8 14 207 10 3 24 232 8 7 38 439 3 6 8 8 1 6 TLPTCA 5 3 11 207 12 9 30 232 9 3 41 439 7 6 12 9 2 3 Target Vessel Revascularization not involving the TL 8 2 17 207 6 5 15 232 7 3 32 439 1 7 3 2 6 6 TV CABG 1 4 3 207 0 9 2 232 1 1 5 439 0 6 1 4 2 6 TV PTCA 6 8 14 207 5 6 13 232 6 2 27 439 1 2 3 4 5 7 Target Vessel Revascularization 15 9 33 207 24 1 56 232 20 3 89 439 8 2 15 6 0 8 TV CABG 7 7 16 207 10 3 24 232 9 1 40 439 2 6 8 0 2 7 TV PTCA 9 2 19 207 14 7 34 232 12 1 53 439 5 5 11 5 0 5 Stent Thrombosis to 30 days 0 0 0 207 0 4 1 232 0 2 1 439 0 4 1 3 0 4 Site Thrombosis Days 31 240 1 0 2 207 0 0 0 232 0 5 2 439 1 0 0 4 2 3 Abrupt Closure 0 0 0 207 0 4 1 232 0 2 1 439 0 4 1 3 0 4 Subacute
46. 4 207 8 2 20 244 7 5 34 451 1 4 6 3 3 4 TLPTCA 5 3 11 207 4 9 12 244 5 1 23 451 0 4 3 7 4 5 Target Vessel Revascularization not involving the TL 8 2 17 207 4 5 11 244 6 2 28 451 3 7 0 9 8 3 TV CABG 1 4 3 207 0 8 2 244 1 1 5 451 0 6 1 4 2 6 TV PTCA 6 8 14 207 3 7 9 244 5 1 23 451 3 1 1 1 7 2 Target Vessel Revascularization 15 9 33 207 16 0 39 244 16 0 72 451 0 0 6 8 6 7 TV CABG 7 7 16 207 8 6 21 244 8 2 37 451 0 9 5 9 4 2 TV PTCA 9 276 19 207 7 876 19 244 8 4 38 451 1 4 3 8 6 6 Stent Thrombosis to 30 days 0 0 0 207 0 0 0 244 0 0 0 451 0 0 Site Thrombosis Days 31 240 1 0 2 207 0 0 0 244 0 4 2 451 1 0 0 4 2 3 Abrupt Closure 0 0 0 207 0 0 0 244 0 0 0 451 0 0 Subacute Closure 0 0 0 207 0 0 0 244 0 0 0 451 0 0 Bleeding Complications 3 4 7 207 1 6 4 244 2 4 11 451 1 7 1 2 4 7 Vascular Complications 1 0 2 207 1 6 4 244 1 3 6 451 0 7 2 8 1 4 CVA 1 0 2 207 0 4 1 244 0 7 3 451 0 6 1 0 2 1 Target vessel revascularization not involving the target lesion was defined as target vessel revascularization at a site other than the target site with te Novoste or without concomitant target lesion revascularization 9 D03745 Rev D
47. 45 Rev D 03 08 Medical Physicist s Kit The Medical Physicist s Kit contains the disposable acces sories required to perform the initial Device Receipt Procedure and to purge fluid from the Transfer Device The Kit contains two 2 3 5F Flushing Adapters two 2 20 ml Three Ring Syringes two 2 Fluid Collection Bags two 2 3 5F Quartz Caps two 2 Syringe Luer Caps Single Use Items B Rail 3 5F Delivery Catheter Figure 4 The B Rail 3 5F Delivery Catheter is a distal rail style catheter that allows the Source Train to be hydraulically deliv ered to and from the targeted site in the coronary vascula ture The Delivery Catheter is provided sterile and is pack aged with the Procedure Accessory Pack which includes the sterile accessories required to perform the procedure B Rail 3 5F Delivery Catheter gt 6F 1 7 mm 0 067 ID guide catheter compatible e lt 0 014 0 36 mm steerable guidewire compatible An open lumen allowing the guidewire to travel over the distal segment of the Delivery Catheter with the wire exiting 1 cm from the distal tip A second lumen contains a preloaded Indicator of Source Train IST with radiopaque markers for 30 mm 40 mm and 60 mm radiation source train positioning while in the catheter Internal radiopaque marker stop at most distal source train position A proximal depth marker positioned approximately 100 cm from the
48. 45 Rev D 03 08 PRECAUTION Illumination of the Red Pressure Indicator A light during a procedure indicates excessive pressure is being used reduce applied pressure to return to the Amber Pressure Indicotor oreo Use fluoroscopy to confirm proper placement of the entire ACTIVE Source Train at the interventional injury site a In the event that the active Source Train cannot be confirmed to have reached the injury site immediately perform the following maneuver to reposition the Active Source Train Confirm the hemostatic valve is open Confirm the Fluid Control Lever is in position Pull to withdraw approximately 1 ml Sterile Water for Irrigation and push to apply forward ressure to the syringe plunger to reposition the Source Train b In the event that the ACTIVE Source Train still cannot be confirmed to have reached the injury site immediately perform the following maneuver to return the ACTIVE Source Train to the ACTIVE Transfer Device e Move the Fluid Control Lever to EMI Depress syringe and apply continuous positive pressure so that all three Amber Pressure Indicator lights are illuminated during the return of the Source Train An audible click will be heard as the active Source Train returns to the Source Chamber Maintain Pressure on the syringe while visually confirming tha
49. 5 0 85 1 07 4 44 0 7342 96 109 28 30 124 138 17 43 8 54 Brachytherapy Success 100 0 96 7 99 3 1 03 0 97 1 11 3 33 0 2158 109 109 29 30 138 139 5 33 11 99 MACE Free at 6 months 81 0 86 2 82 1 0 94 0 79 1 12 5 25 0 5963 85 105 25 29 110 134 22 29 11 78 TVR Free at 6 month 83 8 89 7 85 1 0 93 0 80 1 09 5 85 0 5639 88 105 26 29 114 134 21 36 9 67 MACE at 6 months 19 0 13 8 17 9 1 38 0 51 3 72 5 25 0 5963 20 105 4 29 24 134 11 78 22 29 TVR at 6 months 16 2 10 3 14 9 1 57 0 49 4 97 5 85 0 5639 17 105 3 29 20 134 9 67 21 36 In Hospital MACE 0 9 6 7 2 2 0 14 0 01 1 47 5 75 0 1175 1 109 2 30 3 139 17 13 5 63 Out of Hospital MACE 18 1 10 3 16 4 1 75 0 56 5 50 7 75 0 4057 to 6 months 19 105 3 29 22 134 7 94 23 44 CORE LAB SUBSET ANALYSIS In Analysis Segment 0 21 0 74 0 02 0 59 0 15 0 71 N A 0 22 0 3446 Late Loss at 6 months 37 12 49 0 25 0 70 Stent Segment Late Loss 0 28 0 95 0 38 0 46 0 11 0 90 N A 0 66 0 0028 at 6 months 37 12 49 0 08 1 23 In Analyisis Segment Late Loss Index at 6 1 68 8 41 0 28 0 95 1 34 7 32 N A 1 40 0 3256 Months 37 12 49 6 33 3 52 Stent Segment Late 0 12 x 0 61 0 31 0 44 0 01 0 60 N A 0 43 0 0289 Loss Index at 6 Months 37 12 49 0 05 0 82 In Analysis Segment Binary Restenosis Rate 35 1 8 3 1 12 28 6 14 49 4 22 26 80 0 1391 ot Months 1
50. 6 40 20 f new stent new stent no new no new 1999 2001 stent 1999 stent 2001 O less than months months O months 12 months or more As reported in article submitted by Philip Urban M D FACC for publication in JACC entitled A multicenter European Registry of Intraluminal Coronary Beta Brachytherapy 22 Ge Novoste D03745 Rev D 03 08 ETA CATHD Table 4 Principal Effectiveness and Safety Results RENO Long versus WRIST Long WRIST Control All Patients Treated N 233 Wrist Long Efficacy Measure RENO Long Wrist Control Combined Relative Risk Difference p Value N 139 N 94 N 233 95 C l 95 C l Follow up Done 96 4 100 0 97 9 0 96 3 60 0 0834 134 139 94 94 228 233 0 93 1 00 7 60 0 40 Procedure Success 89 9 81 7 86 6 1 10 8 13 0 0805 124 138 76 93 200 231 0 98 1 23 2 14 18 41 Brachytherapy Success 99 3 89 2 95 3 1 11 10 03 0 0006 138 139 83 93 221 232 1 04 1 20 2 65 17 42 MACE Free at months 82 1 35 1 62 7 2 34 46 98 lt 0001 110 134 33 94 143 228 1 76 3 11 34 39 59 57 TVR Free at 6 month 85 1 39 4 66 2 2 16 45 71 lt 0001 114 134 37 94 151 228 1 67 2 81 33 18 58 25 MACE at 6 months 17 9 64 9 37 3 0 28 46 98 lt 0001 24 134 61 94 85 228 0 19 0 41 59 57 34 39 TVR at months 14 9 60 6 33 8 0 25 45 71 lt 0001 20 134 57 94 77 228 0 16 0
51. 8 19 87 Numbers are counts n or Mean SD Cl Confidence Interval Relative Risk p1 p SE sqrt 1 1 p2 n2p2 Cl RR exp x1 96 SE Difference pj p2 SE sqrt 1 p1 In1 1 p2 1 2 1 Cl diff 1 96 SE 0 5 1 ni 1 n2 NA Not applicable Procedure Success Attainment of a lt 50 residual diameter stenosis using any percutaneous method and no in hospital MACE Brachytherapy Success Attainment of a lt 50 residual stenosis and successful delivery of the radiation device Restenosis was defined at 25076 in stent diameter stenosis at the follow up angiogram If an in stent measurement was not available the In lesion diameter was used In Analysis Segment Stent Probe Edges areas Survival Estimates from Kaplan Meier estimate Standard Error estimate by Peto formula TIr Free No Target Lesion Revascularization Mace Free No Death Q Wave of Non Q Wave MI CABG or Target Vessel Revascularization D Novoste D03745 Rev D 03 08 ETA CATHD Table 7 Principal Effectiveness and Safety Results Pullback versus Non Pullback 60 mm All Patients Treated N 139 Efficacy Measure Pullback Non pullback Combined N 109 N 30 N 139 Relative Risk Difference P Value Follow up Done 96 3 96 7 96 4 1 00 0 92 1 08 0 34 gt 0 9999 105 109 29 30 134 139 9 90 9 22 Procedure Success 88 9 93 3 89 9 0 9
52. 83 167 89 158 99 153 90 166 90 166 89 154 MACE 61 7 97 id 49 7 56 3 02884 mE 64 7 542 0 0680 54 2 57 8 Dom 87 154 721167 72 167 26 158 88 153 75 166 751166 26 154 TR 56 5 43 1 ul 43 1 165 00000 IVR 57 5 45 2 59332 45 2 16 9 9900 Table C8 Cumulative 5 year Comparison of Efficacy Outcomes Variable START START START Placebo START START START Sr t Comparison of percentages calculated using Fisher s Exact Chi Square Placebo Sr 90 5 year Sr 90 40 Sr 90 90 p value lt 0 05 5 year 5 year versus 5 year 5 year 5 year p value lt 001 START Sr 90 Versus p value lt 0 001 5 year START 40 p value Sr 90 5 year p value 101 149 97 155 97 155 95 142 MACE 67 8 626 0 3995 62 6 66 990 0 4673 88 149 79 155 79 155 27 142 x TUR 59 1 51 09 016 8 51 0 19 0 00000 D03745Rev D 03 08 ETA CATHD ETA CATH Novoste Beta Cath B Coth B Rail and Beta Cath System logo design are trademarks of Best Vascular Inc U S Patent Nos 5 683 345 5 899 882 6 013 020 6 261 219 and 6 306 074 Other patents pending 2008 Best Vascular Inc All Rights Reserved 4350 International Blvd Norcross Georgia 30093 Tel 1 770 717 0904 FAX 1 770 717 1283 www teambest com 1 800 NOVOSTE e Novoste D03745 Rev D 03 08
53. 9 0 50 0 28 0 88 20 77 0 0077 Restenosis Rote 10 49 77 187 87 236 35 47 6 06 Numbers are counts n or Mean SD n Cl Confidence Interval Relative Risk 2 SE sqrt 1 1 p2 n2p2 Cl RR exp 1 96 SE Difference p1 p2 SE sqrt 1 1 p1 n1 1 p2 1 p2 n2 1 Cl diff 1 96 SE 0 5 1 n 1 n9 NA Not applicable Procedure Success Attainment of a lt 50 residual diameter stenosis using any percutaneous method and no in hospital MACE Brachytherapy Success Attainment of a lt 50 residual stenosis and successful delivery of the radiation device Restenosis was defined at 25076 in stent diameter stenosis at the follow up angiogram If an in stent measurement was not available the In lesion diameter was used In Analysis Segment Stent Probe Edges areas Survival Estimates from Kaplan Meier estimate Standard Error estimate by Peto formula Mace Free No Death Q Wave of Non Q Wave MI CABG or Target Vessel Revascularization 4g m Novoste D03745 Rev D 03 08 ETA CATH Table 6 Principal Effectiveness and Safety Results RENO Long versus START Radiation All Patients Treated N 383 Efficacy Measure RENO Long START Radiation Combined Relative Risk Difference N 139 N 244 N 383 95 C I 95 C l Volue Follow up Done 96 4 100 00 98 6 N A N A N A 134 139 244 244 378 383 Pro
54. ARNING Radiation is emitted from the active Transfer Device when the Radiation Sources are in the Source Chamber To minimize hand dose the Transfer Device is designed to be held on the under side and may also be set down when appropriate 1 Once the appropriate Beta Cath 3 5F System compat ible Transfer Device Source Train is selected based upon the interventional injury length and desired mar gin coverage confirm the following ACTIVE Transfer Device conditions The radioactive warning symbols are on the device The Gate Control Switch is in the position e The distal radiopaque marker of the ACTIVE Source Train is away from the Gate The Fluid Control Lever is set to The power is turned ON 2 Connect the Fluid Collection Bag to the Fluid Collection Bag Luer Port of the Transfer Device PRECAUTION Handle the Transfer Device carefully If the Transfer Device is dropped do not use Contact your Best Vascular Representative for service 3 Insert the Syringe into the Syringe Port Hole and tighten to Syringe Luer Note To use Fluid Management System Connect a Merit Medical high pressure 200 psi minimum injec tion line or Bes Vascular qualified equivalent to syringe luer connect Merit Medical 3 way stopcock 200 psi minimum to high pressure line and connect a syringe to each port on the stopcock Turn stopcock N fo the primary syringe and proceed with pr
55. Cath 3 5F System is 0 000876 of the annual dose limit and the estimated dose per procedure from the 60 mm Beta Cath 3 5F System is 0 0012 of the annual dose limit Patient Whole Body Dose Per Treatment Fluoroscopy during PTCA 340 mrem 3 4 30 mm Beta Cath 3 5F System 0 19 mrem during treatment and 0 08 mrem during transit for a total of 0 27 mrem 0 0027 mSy per treatment AO mm Beta Cath 3 5F System 0 25 mrem during treatment and 0 11 mrem during transit for a total of 0 36 mrem 0 0036 mSy per treatment 60 mm Beta Cath 3 5F System 0 38 mrem during treatment and 0 16 mrem during transit for a total of 0 54 mrem 0 0054 mSy per treatment The estimated patient whole body dose from the 30 mm Beta Cath 3 5F System is approximately 0 08 of the whole body dose from fluoroscopy during a PTCA the esti mated patient whole body dose from the 40 mm Beta Cath 3 5F System is approximately 0 11 of the whole body dose from fluoroscopy during a PTCA and the estimated patient whole body dose from the 60 mm a Novoste 55 D03745 Rev D 03 08 ETA CATHP Attachment B Additional Dosimetry Information for the Beta Cath 3 5F System continued Beta Cath 3 5F System is approximately 0 16 of the whole body dose from fluoroscopy during a PTCA 1 Data on file Best Vascular Inc 2 Limacher MD MC et al Radiation Safety in the Practice of Cardiology JACC March 15 1998 892 913 3 Harriso
56. Closure 0 0 0 207 0 4 1 232 0 2 1 439 0 4 1 3 0 4 Bleeding Complications 3 4 7 207 1 7 4 232 2 5 11 439 1 7 1 3 4 6 Vascular Complications 1 0 2 207 1 3 3 232 1 1 5 439 0 3 2 3 1 6 CVA 1 0 2 207 0 4 1 232 0 7 3 439 0 5 1 0 2 1 Target vessel revascularization not involving the target lesion was defined as target vessel revascularization at a site other than the target site with or without concomitant target lesion revascularization Major Adverse Events In and Out of Hos Patients Treated N START 40 20 versus S ART START 40 20 N 207 Patients START Sr 90 N 244 Patients All Patients N 451 Patients to 240 days Difference 95 C I Combined In and Out of Hospital Complications to 240 Days Any MACE Death MI Emergent CABG TVR 19 3 40 207 18 0 44 244 18 6 84 451 1 3 5 9 8 5 Death 2 4 5 207 1 2 3 244 1 8 8 451 1 2 1 3 3 7 Myocardial Infarction Q or Non Q 4 3 9 207 1 6 4 244 2 9 13 451 2 7 0 5 5 9 Q Wave MI 1 4 3 207 0 0 0 244 0 7 3 451 1 4 0 2 3 1 Non Q Wave MI 2 9 6 207 1 6 4 244 2 2 10 451 1 3 1 5 4 0 Emergent CABG 0 0 0 207 0 4 1 244 0 2 1 451 0 4 1 2 0 4 Target Lesion Revascularization 11 1 23 207 13 1 32 244 12 2 55 451 2 0 8 0 4 0 TL CABG 6 8 1
57. Collection Bag Use a docu mented technique of known efficiency to assess the radioactive contents of the vial b If a planchet counter is used apply the fluid from the Fluid Collection Bag onto a planchet Allow the fluid in the planchet to evaporate Use a planchet counter with known counting efficiency for Sr Y beta radiation to evaluate the planchet 11 Record results of the count on your Institution s Radiation Procedure Record I results exceed 11 100 dpm notify your Radiation Safety Personnel 38 ae Novoste D03745 Rev D 03 08 ETA CATH PRECAUTION f the Leak test results exceed 11 100 dpm or the level determined by local reg ulation or institutional policy on any sample place the device in a plastic bag and label Caution Radioactive Material Immediately inform institu tional Radiation Safety personnel implement con tainment control procedures and call your Best Vascular Representative Should this occur do not continue with this procedure 12 Insert Quartz Cap into Proprietary Connector recep tacle Place the Syringe Luer Cap over the Syringe Luer of the Transfer Device and store in accordance with institutional policy C Therapy Planning CARD RO MP RSO D With the Beta Cath 3 5F System recommended prescription doses are as follows Reference Recommended Prescription Dose Vessel Diameter for In Stent Restenosis gt 27 lt 3 35 mm 18 4 Gy gt 3 35 lt 4 0 23 0 Gy
58. Disposition of START and START 40 20 PAS Subjects Disposition of Study Subjects START p All Patients All Patients Completed original START START 40 20 Study 476 207 Enrolled in START START 40 20 PAS Study 192 87 Completed START START 40 20 PAS 5 year follow 192 81 up visit Discontinued the study prior to 5 year follow up visit 66 23 Main reason for early termination prior to 5 year visit Death 22 6 No Recorded info on Death 6 2 Cardiac 8 3 Non cardiac 8 1 Lost to follow up 26 7 Withdrawal of consent 22 10 Missing Incomplete Data on Term CRF 0 0 Determined by number of patients with data for one or more of the 3 4 or 5 year intervals 59 D03745 Rev D 03 08 Attachment C START and START 40 20 5 year Follow Up Continued Table C3 3 4 and 5 Year Safety and Efficacy Outcomes START and START 40 PAS START Sr 90 Start Placebo START START START40 START START START40 START START START40 8 months 8 months Sr 90 Placebo 51 90 51 90 Placebo Sr 90 Sr 90 Placebo Sr 90 3 year 3 year 3 year 4 year 4 year 4 year 5 year 5 year 5 year 244 232 93 67 87 101 13 83 107 85 81 Variable N N N N N N N 44 18 0 60 25 9 7 T5 10 14 9 9 10 3 10 9 9 6 82 1
59. Ensure that the Gate Control Switch is completely closed as incomplete closure 4 Disconnect the and the Extension Connector may render the Gate inoperable rom the Transfer Device 5 Return the Transfer Device with attached Fluid Collection Bag and Delivery Catheter to 8 Perform a Survey of the patient s chest and groin area and note results MP RSO for Safety Check and Drying M Delivery Catheter Removal card Post Procedural Radiation 1 Remove the entire Beta Cath 3 5F System under Checks MP RSO D fluoroscopy as a single unit while maintaining guide wire placement PRECAUTION Failure to perform adequate visual and radiation surveys post procedure to WARNING Never withdraw the Delivery Catheter verify source accountability may subject patients against resistance If any resistance is felt stop imme and or personnel to unintended radiation exposure diately and determine the cause of resistance before 1 Confirm presence of the Source Train in the proceeding Catheter damage and or patient injury Transfer s Id 2 Survey the Transfer Device with the Fluid Collection Bag still connected and note results PRECAUTION Exercise care when withdrawing the 3 Remove the ACTvE Delivery Catheter through any area of increased restric tion such as a stent guide catheter tip or hemostatic valve Always withdraw the Delivery Catheter slowly 4 Survey th
60. ING Migration of the Active Source personnel Train or improper location of the Active Source Train may cause unintentional radiation exposure to occur and may decrease treatment efficacy Move the Fluid Control Lever to GE 4 Depress syringe and apply continuous pressure so Co that all three Amber Pressure Indicator lights are illuminated during the return of the crv Source 10 Start Treatment time once Cardiologist confirms that Train An audible click will be heard as the ACTIVE the ACTNVE Source Train is across the entire inter Source Train returns to the Source Chamber ventional injury site 5 Maintain pressure on the syringe while visually con firming that the acrive Source Train is located within the Source Chamber and that the Green Arrow 11 Consult the Medical Physicist to confirm the treatment time for the prescribed dose Indicator light is ON WARNING Exceeding the prescribed radia ss tion treatment time will result in a higher than 6 Visually confirm that the acte Source Train is locat intended dose ed in the Source Chamber and the distal radiopaque marker of the jacketed Source Train is clearly present a In the event that the entire Source Train cannot be confirmed to have returned to the ACTIVE Transfer Device after the treatment immedi 12 Monitor patient
61. Involving Use of the Temporary Storage Container 1 Bail Out is defined as physician use of the Novoste Temporary Storage Container 10 Novoste D03745 Rev D 03 08 ETA CATHP The original Beta Cath 5F System was evaluated in a subset analysis of the European Surveillance REgistry with the NOvoste Beta Cath System RENO Registry a prospective commercial registry at 46 cen ters in Europe involving 1098 patients This subset anal ysis included a comparison of 139 patients from the RENO registry RENO Long Subgroup that had diffuse in stent restenotic lesions in single vessels treated by longer than 40 mm of radiation source train as com pared to a placebo control group 94 patients obtained from the WRIST and LONG WhRIST studies by selecting the cases which required longer or equal to 13 seeds of dummy sources and to the START trial results Additionally comparisons were made between the pull back and 60mm source train groups of the RENO Long Subgroup to ensure the outcomes could be pooled Treatments with the Beta Cath 5F System included stepping pullback procedures utilizing either 30 40 or 60 mm source trains or a single 60 mm source train The adverse events summorized in the following tables RENO Long versus WRIST Long WRIST Control Major Adverse Events In and Out of Hospital to 6 months All Patients N 233 Combined In and Out RENO Long WRIST Lo
62. J PRECAUTION The magnetic Source Recovery Probe should be held and operated near its release lever in order to avoid unnecessary radiation exposure 4g LP Rev D 03 08 e Novoste ETA CATHD 7b Alternatively the spring loaded Tweezers may be used to pick up the Source s and place it in the Source Container 8 When all missing ACTIVE Sources have been located and placed in the water in the Source Container screw the lid back on the container and move the container to a safe secure location 9 Mark the Source Container with a Radioactive Materials sticker Lock the container in a secure location to prevent unauthorized handling of the Source s 10 Call your Best Vascular Representative immediately to assist with returning the recovered Source Train and ACTIVE Transfer Device to Best Vascular Inc Temporary Storage Container Cleaning IF the Temporary Storage Container is used to store a contaminated system during the return of an Source Train into the ACTIVE Transfer Device the Temporary Storage Container should be cleaned Please refer to institutional Hospital Infection Control Procedures for cleaning biohazardous materials R Optional Instructions CARD D 1 IST Reinsertion The following is the recommended procedure for maintain ing field sterility when IST into the Delivery Catheter for re advancement of t repositioning IST reinsertion shou
63. O Long sub group Radiation was prescribed in the RENO registry according to the following schema Without stent 16 1 Gray at 2 mm if a maximum balloon diameter of gt 2 5 mm 3 5 mm was used or e 20 7 Gray at 2 mm if a maximum balloon diameter of 3 5 mm 4 0 mm was used or e 23 0 Gray at 2 mm if a maximum balloon diameter of 2 4 0 mm was used With stent implantation In stent restenosis or radiation after stent implantation 18 4 Gray at 2 mm if a maximum balloon diameter of gt 2 5 mm 3 5 mm was used or 23 Gray at 2 mm if a maximum balloon diameter of 3 5 mm 4 0 mm was used or e 25 3 Gray at 2 mm if a maximum balloon diameter of 2 4 0 mm was used Beta Cath System is not indicated for pullback stepping e Novoste 21 D03745Rev D 03 08 escam SYSTEM The antiplatelet anticoagulant regime administered for begun and the second in April 2001 at the time the last RENO was assessed with two questionnaires that were patients were followed up for their 6 month visit The sur sent to investigators to define the prescribed duration of vey demonstrated that most patients received greater than antiplatelet therapy The first questionnaire was sent in at least 6 months of antiplatelet therapy The results of July 1999 3 months after patient recruitment had the survey are as follows Duration of combined antiplatelet regimen following VBT in the RENO Registry 100 80 60 7
64. User s Manual Beta Cath 3 5F System For use with the B Rail 3 5F Delivery Catheter or the B Rail 3 5F XL Delivery Catheter CAUTION Federal USA law restricts this device to sale by or on the order of a physician ae Novoste D03745 Rev D 03 08 V Table of Contents veces tes How To Use This j SystemdDesernipltiem Suyu St Ill Essential Prescribing Information Indications uctor rtr Contraindications Warnings Precautionis cete Special mem Adverse EVENS cc s Major Adverse Events START 40 20 Major Adverse Events START 40 20 vs START placebo Major Adverse Events START 40 20 vs START Sr 90 a asssasssssssassnasnsn nssqa reete ertet Major Adverse Events RENO Long vs WRIST Lengu uu aasan e Major Adverse Events RENO Long vs START placebo Major Adverse Events RENO Long vs START radiation Pullback vs Non Pullback 60 mm smm Antiplatelet Therapy 2 eo d en Yea
65. al radiopaque markers The princi pal radiation emission is beta particles with energies up to 2 27 MeV Sr Y has a radioactive halflife of 28 8 years The long half life simplifies treatment planning due to the slow rate of radioactive decay The presence of the black and yellow AN Rodiooctive Worning Symbol will identify the Transfer Device An optional Transfer Device will contain a NON ACTVE Source Train consisting of 16 40 mm Source Train miniature cylindrical Non active sources and two one distal and one proximal radiopaque markers This Transfer Device is NOT RADIOACTIVE and will be labeled Non active 28 D03745 Rev D 03 08 2 The Novoste B Rail 3 5F Delivery Catheter is a single use closed end catheter with a 1 cm distal rail segment The Source Train is transported to the treat ment site and back into the Transfer Device through the Delivery Catheter The Delivery Catheter is compatible with the 30 mm 40 mm and 60 mm versions of the Beta Cath 3 5F System compatible Transfer Device The Delivery Catheter is supplied sterile and includes an Indicator of Source Train IST pre loaded into the Delivery Catheter and a Flushing Cannula The IST aids in the measurement and positioning of the Delivery Catheter to ensure placement of the radioactive Source Train across the entire interventional injury The Proprietary Connector connects the Delive
66. ameter stenosis using any percutaneous method and no in hospital MACE Brachytherapy Success Attainment of a lt 50 residual stenosis and successful delivery of the radiation device Restenosis was defined at gt 50 in stent diameter stenosis at the follow up angiogram If an in stent measurement was not available the In lesion diameter was used In Analysis Segment Stent Probe Edges areas Survival Estimates from Kaplan Meier estimate Standard Error estimate by Peto formula Mace Free No Death Q Wave of Non Q Wave Ml CABG or Target Vessel Revascularization aa u Novoste 23 D03745Rev D 03 08 ETA CATH Figure 3 Principal Effectiveness and Safety Results RENO Long versus WRIST Long WRIST Control 6 Month Freedom from MACE Survival Probability Placebo 0 30 60 90 120 150 180 210 Time in days Summary Statistics Total Events Censored Event Free RENO 134 24 110 82 09 Control 94 61 33 35 11 Tests Berween Groups Chi Square d o f P Value Log Ronk 49 1 lt 0001 Wilcoxon 55 2 lt 0001 2 eb Novaste D03745 Rev D 03 08 ETA CATHD Table 5 Principal Effectiveness and Safety Results RENO Long versus START Placebo All Patients Treated N 371 Efficacy Measure RENO Long START Placebo Combined Relative Risk Difference N 139 N 232 N 371 95 C l 95 C l Value Follow up Done 96 4 100 0 98 7 0 96 0 93 1 00 3 60 0
67. andling of materials specific to the Beta Cath 3 5F System It is the user s responsibility to keep accu rate records of the number of treatments administered with each ACE Transfer Device The Active Transfer Device will be shipped in a White Lead Lined Storage Container placed inside a Type A shipping container conspicuously marked with a Yellow II ACTIVE Transfer radiation label Upon receipt of the Device carefully inspect all components perform an ini tial inspection wipe test and leak test if required in an area designated or radioactive materials handling before placing the Transfer Device in the White Lead Lined Storage Container and into the Transport Case Note The Exchangeable Battery Transfer Device requires insertion of the Volt Lithium ion battery that is located in the foam insert placed over the Transfer Device as described on page 31 PRECAUTION The individual paoia the wipe tests for leaking radioactive material should use good contamination control techniques 1 Using a portable Radiation Survey Meter which is capable of detecting beta radiation and measuring radiation levels from background to 1 rad hour determine the highest levels of radiation at contact and at one meter from the shipping container Record results on your Institution s Radiation Procedural Recorda 2 Wipe discrete locations on the outside of the ship ping container tota
68. arget vessel Aneurysm was defined as an expansion of the lumen by at least 20 compared with the normal lumen dimensions in the treatment region analyzed segment that extends with a wide or narrow mouth beyond the apparent normal contour Baseline QCA for START Sr 90 patient 15 3 revealed the presence of an aneurysm The Angiographic Core Laboratory reported the absolute size of the aneurysm changed very little from baseline to follow up and that the larger appearance at follow up was due to the smaller reference vessel dimension rather than an increase in aneurysm size Total Occlusion An MLD of zero at follow up as assessed by QCA 19 D03745 Rev D 03 08 ETA CATH Figure 2 Freedom from Target Vessel Failure at 240 days Event free Survival 1 5SE All Patients Treated N 439 START 40 20 versus START Placebo 90 80 70 Freedom from TVF START 40 20 START Placebo 6076 0 30 60 90 120 150 180 210 240 Time after initial procedure days Time after initial procedure days 0 30 60 90 120 150 180 210 240 START 40 20 Entered 207 20 199 193 189 183 179 174 162 Lost to Follow up 0 2 2 0 0 1 2 4 14 Incomplete 0 0 0 0 0 0 0 0 0 At risk 207 0 205 0 198 0 193 0 189 0 182 5 178 0 172 0 155 0 Events 1 5 4 4 3 3 8 Events Month 5 4 4 6 3 3 8 6 Survived 99 5 97 1 95 1 93 2 90 2 88 7 87 2 83 2 80 0 SE 0 5 1 2 1 5
69. ars 4 years Reported At 5 years 5 years Reported At Through Through 4 years 5 years 2 years 2 years N 244 N 232 N 167 N 154 N 158 N 166 N 153 N 154 N 155 N 149 N 142 n n n n n n n n n n n Total MACE 76 314 91 392 8 497 95 617 89 56 3 90 542 99 647 89 57 8 97 626 1001 67 8 95 66 9 Death 8 33 11 47 8 48 12 18 14 8 9 11 6 6 13 8 5 16 10 3 13 8 3 14 94 17 11 8 Mes to sefe 48 m a4 a ss w TLR 59 242 TT 332 60 359 78 50 6 61 38 6 61 367 79 51 6 62 403 62 400 79 530 65 458 Total TVR 68 279 86 37 1 72 43 41 8 565 26 16 5 75 45 2 88 57 5 26 16 9 79 510 8 591 27 19 0 pem 41 168 41 7 7 4 254 4 23 6 3 8 42 253 42 27 5 6 3 9 4 27 1 42 282 6 42 38 156 57 246 40 240 57 37 24 15 2 42 253 58 37 9 25 16 2 45 29 0 58 389 27 19 0 Aneurysm 1 04 0 0 0 1 0 6 0 0 0 2 13 1 0 6 0 0 0 2 13 1 0 6 0 0 0 2 14 i i t A Table C6 Cumulative 3 year Comparison of Efficacy Outcomes Table C7 Cumulative 4 year Comparison of Efficacy Outcomest Variable START START START Placebo START START START Sr Variable START START START START START START Sr Placebo Sr 90 3 year Sr 90 40 Sr 90 90 Placebo Sr 90 Placebo Sr 90 40 Sr 90 90 3 year 3 year versus 3 year 3 year 3 year 4 year 4 year 4 year 4 year 4 year 4 year START Sr 90 versus versus versus 3 year START 40 START START 40 p value Sr 90 3 Sr 90 Sr 90 4 year year 4 year p value p value p value 95 154 83 167
70. atistical significance was not reached at 5 years the results were numerically in favor of Sr 90 Similarly continued significance in favor of Sr 90 was demonstrated for TVR rates at the 3 and 4 year follow up statistical significance was not reached at 5 years but the results were numerically in favor of Sr 90 Sr 90 demonstrated a benefit beyond the earlier reported 8 month 1 year and 2 year results with no evidence of late catch up proliferative effect or safety issues START 40 20 vs START Sr 90 No statistical differences were demonstrated between the START 40 20 and START Sr 90 groups for MACE at 3 4 or 5 years A significant difference in the TVR rate in favor of START 40 20 compared to the START Sr 90 group was seen at the 3 4 and 5 year endpoints The 5 year results for START 40 20 also demonstrated a continued benefit without evidence of late catch up proliferative effect or safety issues A significantly lower rate of TVR for START 40 20 patients through 5 years is suggestive of the additional benefit provided by using a longer source train to better match the injury length but was not conclusive based on the data available The long term follow up of the START and START 40 20 trials out to 5 years demonstrated the benefit of Sr 90 beyond the earlier reported 2 year follow up for both trials Additionally this long term follow up demonstrated no safety concerns or reversal of benefit out to 5 years Table C2
71. atment assignment adjudicated all major end points Eligible patients with angina or a positive func tional study were identified for elective treatment of in stent restenosis in a native coronary artery lesion visually estimated to be between 2 7 and 4 0 mm in diameter and treatable with up to a 20 mm length angioplasty balloon These patients underwent successful percuta neous coronary interventions defined as revasculariza tion by balloon angioplasty directional and rotational atherectomy and excimer laser after which treatment with the randomized Beta Cath 5F System active or 14 D03745 Rev D 03 08 placebo was administered After the vascular brachyther apy treatment additional percutaneous coronary inter ventional techniques or devices were utilized as deemed necessary by the clinician Placement of a new stent while discouraged occurred at the discretion of the clini cian in 21 n 101 of the cases Radiation was prescribed according to the following ref erence vessel diameter 2 7 3 35 mm received 18 4 Gy and gt 3 35 lt 4 0 mm received 23 Gy at a dis tance 2mm from the centerline of the source train 18 4 and 23 Gray reflect the NISTrecommended adjustments to the documented doses as described in Technical Report DSGN 0311 A and are equivalent to the 16 and 20 Gray docu mented doses described in the START Trial The Antiplatelet Anticoagulant regimen administered for the 476 patients in t
72. atment of lesions treatable with a 20 mm Balloon with a 30 mm Source Train 95 using the Beta Cath 5F System The acute and 8 month clinical and angiograph ic results showed that the procedure success rate defined as the attainment of a residual stenosis of 5096 without in hospital major adverse cardiac events MACE death Q wave and non Q wave MI emergent CABC and tar et vessel revascularization was 97 1 237 244 in the Sr 90 arm and 97 0 225 232 in the Placebo arm p 0 9237 The Kaplan Meier estimate of freedom from MACE at 8 months was 81 4 in Sr 90 arm and 72 2 in the Placebo arm p 0 0393 The Kaplan Meier estimate of freedom from target vessel failure defined as target vessel revascularization MI or death at 8 months was 81 4 in Sr 90 arm and 72 2 in the Placebo arm p 0 0393 A total of 476 patients were enrolled at 50 US Canadian and European investigational sites in the placebo controlled triple masked multicenter START Trial All 476 of the enrolled patients were randomized to receive either the active Beta Cath 5F System n 244 or placebo Beta Cath 5F System n 232 The primary endpoint of 8 month clinical target vessel failure was defined as the composite of death myocardial infarction Qwave and non Q wave coronary artery bypass graft surgery CABG and revascularizations attributed to the target vessel TVR A clinical events committee masked to the tre
73. cedure Success 89 9 97 1 94 5 0 93 0 87 0 98 7 28 0 0042 124 138 237 244 361 382 13 32 1 23 Brachytherapy Success 99 3 N A N A N A N A N A 138 139 MACE Free 82 1 82 0 82 0 1 00 0 91 1 11 0 12 gt 0 9999 110 134 200 244 310 378 8 57 8 81 TVR Free 85 1 84 0 84 4 1 01 0 93 1 11 1 06 0 8825 114 134 205 244 319 378 7 13 9 25 MACE 17 9 18 0 18 0 0 99 0 63 1 56 0 12 gt 0 9999 24 134 44 244 68 378 8 81 8 57 TVR 14 9 16 0 15 6 0 93 0 57 1 53 1 06 0 8825 20 134 39 244 59 378 9 25 7 13 In Hospital MACE 2 3 2 5 2 4 0 93 0 24 3 66 0 17 gt 0 9999 3 131 6 244 9 375 3 98 3 64 Out of Hospital MACE 16 4 16 0 16 1 1 03 0 64 1 66 0 43 gt 0 9999 22 134 39 244 61 378 7 95 8 81 CORE LAB SUBSET ANALYSIS In Analysis Segment 0 15 0 71 0 28 0 56 N A N A 0 13 0 32 0 06 0 2373 Late Loss 49 198 Stent Segment Late Loss 0 11 0 90 0 21 0 61 N A N A 0 10 0 31 0 11 0 4641 49 197 In Analyisis Segment 1 34 7 32 0 35 1 06 N A N A 1 69 2 75 0 63 0 1135 Late Loss Index 49 198 Stent Segment Late Loss 0 01 0 60 0 09 1 28 N A N A 0 08 0 45 0 29 0 5236 Index 49 197 In Analysis Segment 28 6 28 8 28 7 0 99 0 61 1 63 0 22 gt 0 9999 Binary Restenosis Rate 14 49 57 198 71 247 15 75 15 32 Stent Segment Binary 20 4 14 2 15 4 1 44 0 75 2 75 6 19 0 2767 Restenosis Rate 10 49 28 197 38 246 7 4
74. ction permanent damage to a body struc ture necessitates medical surgical intervention to pre clude permanent impairment damage to a body func tion structure WARNING A WARNING statement is used to alert the user to a potential serious outcome or harm death injury or serious adverse events to the user or to the patient associated with the use or misuses of the device PRECAUTIONS A precaution statement alerts the user to exercise special care necessary for the safe and effective use of the device Precautions may include actions to be taken to avoid effects on patients or users that may not be potentially life threatening or result in serious injury but also alert the user to adverse effects on the device of use or misuse and the care necessary to avoid such effects Note A note provides additional information to clarify a point in the text Notations In Manual CARD D Performed by Cardiologist or Designee RO D Performed by Radiation Oncologist or Designee e Novoste Performed by Medical Physicist Radiation MP RSO D Safety Officer or Designee Performed by Radiation Oncologist RO MP RSO D Medical Physicist Radiation Safety Officer or Designee Il System Description The Beta Cath 3 5F System is an integrated system comprised of four components the BRail 3 5F Delivery Catheter Transfer Device the Source Train and the System Accessories The System is designed so that the Transfer Devic
75. dictable results during use Do not use the Delivery Catheter if there is evidence of fluid leakage other than at the IST hub vent posi tion Use caution when connecting the Proprietary Connector to the Transfer Device The Proprietary Connector of the Delivery Catheter is no longer ster ile once disconnected from the Transfer Device Use care when attaching components to the Transfer Device to ensure that the Sterile Bag does not get pinched in the process Ensure a sufficient number of water filled syringes are available before begin ning treatment Always reserve at least 10 ml of water for the return of the Source Train to prevent unintentional radiation exposure If the self diagnostic test is not observed do not use the device and call your Best Vascular Representative for service Do not begin a procedure if the Low Battery light is blinking If the Low Battery Indicator starts blinking during a procedure there will be enough battery power to complete the procedure Should this occur replace the battery per instructions found on page 31 of this User s Manual Do not force the connector lock latch into position If resistance is felt reposition the 3 5F compatible Flushing Adapter to ensure proper engagement with the Transfer Device Do not force the connector lock latch into position If resistance is felt reposition the proprietary connector to ensure proper engagement with th
76. e Source s Ensure that the object does not come in direct contact with the ACTIVE Source s but is only used to shield the ACTIVE Source s 6 Fill the Source Container found in the Response Kit approximately two thirds full of water to provide shielding for the active Source s PRECAUTION The Response Kit contains two Source Recovery Tools for picking up and transferring a Source s to a safe location a the Source Recovery Probe and b the spring loaded Tweezers The Source Recovery Probe is the preferred method as it mini mizes potential damage to the Source s and permits the operators hand to be placed further from the Source s PRECAUTION Under undefined handling conditions outside the System the ACTIVE Source Train jacket may be Tao allowing individual active Sources to be released Use care when locating and handling the Radioactive Source Train to ensure that all indi vidual ACTIVE Sources remain intact jacketed and are recovered and returned to safe shielded storage Zo The magnetic Source Recovery Probe will pick up a source when the narrow end of the magnetic Probe is placed near the source The Source s can be released into the water in the Source Container when the Source s are within the Source Container and the release lever on the other end of the probe is raised
77. e Delivery Catheter and Catheter by depressing the Proprietary Connector guicewire rom patent Lock Latch such that the blue line is no longer visible Place the o Catheter and ACTIVE Transfer 3 Disconnect the Delivery Catheter from the Device still attached into Temporary Storage Transfer Device by depressing both squeeze tabs Container Refer to Section Q ie iets located on the Proprietary Connector while with Source Train Recovery Procedure for further drawing the Proprietar asan from the instructions Transfer Device If the Delivery Catheter will not dis connect from the ACTIVE Tarsier Device place the WARNING Avoid direct contact with unshielded entire system into the Temporary Storage Container radiation sources in the Delivery Catheter as unin and refer to Section Q Emergency Source Train tended radiation exposure will occur Recovery for further instructions WARNING Do not grasp catheter directly with a The didi o E hands or cut the catheter as unintended radiation e dear at n id onger sterile IM exposure may result outside the sterile field or disconnected from the scrive Transfer Device Care should be taken not to contam 7 While continuing to apply pressure on syringe slide inate the sterile field If contamination is believed to the Gate Control Switch to the position have occurred take appropriate steps to re establish a sterile field PRECAUTION
78. e Delivery Catheter and capped Fluid and observe under fluoroscopy whenever possible Collection Bag and note results These readings should be to the initial background readings noted Transfer Device from the Sterile Bag disconnect and cap the Fluid Collection Bag PRECAUTION f the guidewire prolapses during E Delivery Catheter withdrawal attempt to resolve the WARNING If the fluid in the capped Fluid prolapse by gently pulling back on the guidewire while Collection Bag is found to be contaminated after simultaneously advancing the catheter If the prolapse scanning then the Transfer Device and capped Fluid persists and cannot be resolved withdraw the Delivery Collection Bag should be placed in the Temporary Catheter and guidewire together as one unit Storage Container and returned to the radiation vault to await inspection by the Radiation Personnel 46 a Novoste D03745 Rev D 03 08 ETA CATHP 5 Survey the procedure room and note results WARNING If Survey readings are significantly different from the initial background reading cease all activity and refer to Section Q Emergency Source Train Recovery 6 After the post procedural Radiation Survey the ACTIVE Transfer Device must be dried see Section P Drying and Storing of the Transfer Device P Drying and Storing of the Transfer Device RO MP RSO D The following is the recommended procedure for pr
79. e Transfer Device 99 Novoste 5 D03745 Rev D 03 08 ETA CATH III Essential Prescribing Information PRECAUTIONS continued Ensure that the Gate Control Switch is completely closed as incomplete closure may render the Gate inoperable Intravascular Radiation Procedure D03745 Rev D 03 08 The individual performing the wipe and leak tests for radioactive material should use good contamination control techniques If the transferable contamination exceeds 200 dpm 100 or the level determined by local regulation or institutional policy or the leak test results exceed 11 100 dpm or the level determined by local regulation or institutional policy on any sam ple place the contaminated object s in a plastic bag and label Caution Radioactive Material Immediately inform institutional Radiation Safety per sonnel implement containment control procedures and call your Best Vascular Representative Should this occur do not continue with this procedure Use only the 3 5F compatible Flushing Adapter pro vided with the Beta Cath 3 5F System Use P other Beta Cath Flushing Adapter will result in an improper fit and an inability to properly perform the Leak Test Procedure Always advance the Delivery Catheter with the IST in posi tion within the Delivery Catheter Never advance or with draw the Delivery Catheter against resistance Do not advance the Delivery Catheter over the floppy portion of the
80. e and the Delivery Catheter are exclusively compatible The BRail 3 5F Delivery Catheter provides the path through which the Source Train is delivered to and retrieved from the site of interventional injury Note This manual is for use with the B Rail 3 5F Delivery Catheter and the Rail 3 5F XL Delivery Catheter The B Rail 3 5F Deliver Catheter may only be used inside the sterile Field using the Sterile Bag the BRail 3 5F XL Delivery Catheter may be used inside or outside the sterile field When the BRail 3 5F Delivery Catheter is referenced it applies to both the BRail 3 5F Delivery Catheter and BRail 3 5F XL Delivery Catheter unless otherwise spec ified Section H is specific to preparing the BRail 3 5F Delivery Catheter for use inside the sterile field an Section is specific to using the BRail 3 5F XL Delivery Catheter outside the sterile field The ergonomically designed Transfer Device stores and shields the Source Train when not in use and controls the hydraulic delivery and return of the Source Train during the treatment procedure The gray color coded Novoste Transfer Device is exclusively compatible with the B Rail M 3 5F Delivery Catheter and Rail 3 5F XL Delivery Catheter 3 D03745 Rev D 03 08 ETA CATH III Essential Prescribing Information The Source Train consists of a wire jacketed series of indi vidual cylindrical sealed sources containing Sr Y and an
81. e power is turned ON 42 D03745 Rev D 03 08 2 Connect the Fluid Collection Bag to the Fluid Collection Bag Luer Port of the ACTIVE Transfer Device and cup the Fluid Collection Bag around the bottom of the device PRECAUTION The Transfer Device is not sterile A Sterile Bag is provided to maintain a sterile field during the procedure Handle the Transfer Device carefully If the Transfer Device is dropped do not use Contact your Best Vascular Representative 3 Using aseptic technique place lah hands inside the U cuffs of the Sterile Bag Carefully place the non sterile ACTIVE Transfer Device with the attached Fluid Col lection Bag into the Sterile Bag Orient the Transfer Device Syringe Luer toward the Syringe Port Hole of the Sterile Bag Refer to Figure 9 Unfold cuffs of the Sterile Bag and secure the Transfer Device by folding the proximal end of the Sterile Bag two 2 times and secure with adhesive strip Figure 9 Sterile Bag Tape Covering Centering Ring PC Receptacle Tape Covering Centering Ring Syringe Port Hole Adhesive Strip zt 4 Align the centering ring of Syringe Port Hole of the Sterile Bag over the Syringe Luer of the ACTIVE Transfer Device Remove the proximal tape covering the Port Hole of the Sterile Bag and secure in place PRECAUTION The inside portion of the tape covering the Syringe Port Hole is not sterile
82. e to follow up and that the larger appearance at follow up was due to the smaller reference vessel dimension rather than an increase in aneurysm size Total Occlusion An MLD of zero at follow up as assessed by QCA 15 D03745 Rev D 03 08 ETA CATH Figure 1 Freedom from Target Vessel Failure at 12 months Event free Survival 1 5SE All Lesions Treated n 476 START Trial versus Placebo 100 90 80 709 60 50 40 0 30 60 90 120 150 180 210 240 270 300 330 360 Time after initial procedure days Time after initial procedure days 0 30 60 90 180 210 240 270 360 Sr 90 Entered 244 241 231 222 217 201 195 179 151 Lost to Follow up 1 1 4 0 1 0 12 19 145 Incomplete 0 0 0 0 0 0 0 0 0 At risk 243 5 240 5 229 0 222 0 216 5 201 0 189 0 169 5 78 5 Events 2 9 5 5 15 4 9 5 Events Month 9 5 5 5 4 3 2 Survived 99 2 95 5 93 4 91 2 84 9 82 4 80 7 76 2 73 6 SE 0 6 1 4 1 6 1 9 2 3 2 5 2 7 3 0 37 8 Placebo Entered 232 230 219 213 203 176 172 160 134 Lost to Follow up 0 5 1 1 0 0 4 14 122 Incomplete 0 0 0 0 0 0 0 0 0 At risk 232 0 227 5 218 5 212 5 203 0 176 0 170 0 153 0 73 0 Events 2 6 5 9 27 4 8 12 12 Events Month 6 5 9 9 4 8 4 4 Survived 99 1 96 5 94 3 90 3 78 3 76 5 72 9 67 1 60 9 SE 0 6 1 3 1 6 2 0 2 8 2 9 3 0 3 3 38 1 Test Between Groups Test Chi Square Deg F
83. eplace with a filled syringe prior to sending the ACTIVE Source Train PRECAUTION Ensure a sufficient number of water filled syringes are available before beginning treatment Always reserve at least 10 ml of water for the return of the active Source Train to prevent unintentional radiation exposure 2 Ensure that hemostatic valve is in the position WARNING Failure to open the hemostatic valve may prevent the radiation source train from returning to the device and may result in unnecessary radiation exposure to the patient or personnel 3 Ensure that power is ON depress the ON OFF but ton if power has turned OFF A Slide the Gate Control Switch forward until the Blue Arrow aligns with the position Note If the Gate Control Switch cannot be moved to the open position and the green SOURCES IN LED is illuminated then move the Gate Control Switch back to the fully closed position and power down the Transfer Device Restart the Transfer Device and proceed as normal 5 Move the Fluid Control Lever to 6 While observing with depress the syringe plunger to transport the ACTIVE Source Train to the Interventional Injury Site of the Delivery Catheter All three Amber Pressure Indicator lights should be illuminated while SENDING the ACTIVE Source Train An audible click will be heard as the AcTIVE Source Train leaves the Source Chamber 44 D037
84. epping procedure below The User may elect to not use the stopcock and connect the directly onto the high pressure exlension tubing See Figure 10 4 Wet tip of the Delivery Cotheter Proprietory Connector with Sterile Water for Irrigation to ease insertion and insert the Proprietary Connector of the Delivery Catheter into the Proprietary Connector Receptacle of the Transfer Device Rotate Proprietary Connector to ensure a secure connection 5 Lock the Proprietary Connector to the ACTIVE Transfer Device by fully depressing the Proprietary Connector Lock Latch until a blue line is visible PRECAUTION Do not force the connector lock latch into position If resistance is felt reposition the propri etary connector to ensure proper engagement with the Transfer Device 43 D03745 Rev D 03 08 ETA CATH J Transfer Device Priming RO D 1 Ensure that the Gate Control Switch is in the position 2 Ensure that the Fluid Control Lever is on BR 3 Flush Transfer Device and Delivery Catheter System with 6 ml of Sterile Water for Irrigation Confirm the device is primed properly by observing the absence of air bubbles and the entry of water into the Fluid Collection Bag K Delivery of the Source Train 1 Check for adequate 14 ml minimum fluid volume in the syringe Note If using Fluid Management System turn stop cock to secondary syringe if additional fluid is required or r
85. erform adequate visual and radiation sur veys postprocedure to verify source accountability may subject patients and or personnel to unintended radi ation exposure Emergency Source Recovery Under the undefined handling conditions outside the System the LACTIVE Source Train jacket may be dam aged allowing individual ACTIVE Sources to be released Use care when locating and handling the Radioactive Source Train to ensure that all individual ACTIVE Sources remain intact jacketed and are recov ered and returned to safe shielded storage The Response Kit contains two Source Recovery Tools for picking up and transfering a Source s to a safe location a the Source Recovery Probe and b the spring loaded Tweezers The Source Recovery Probe is the preferred method as it minimizes potential damage to the Source s and permits the operator s hand to be placed further from the Source s The magnetic Source Recovery Probe should be held and operated near its release lever in order to avoid unnecessary radiation exposure n the event a source becomes loose or needs to be transferred to a safe location use the source recovery tools with extreme care in source recovery Improper use could damage sources and could potentially release unsealed radioactive material Use of the Source Recovery Probe is the preferred method as it minimizes potential damage to a source gA Novoste III
86. essful delivery radiation therapy was 89 9 124 138 as compared to 81 7 76 93 in the WRIST Long Wrist Control Group 97 0 225 232 in the START Placebo Group and 97 1 237 244 In the START Radiation Group Freedom from MACE 6 month for RENO Long and WRIST Long WRIST and 8 month for START was 82 1 110 134 as compared to 35 176 33 94 in the WRIST Long Wrist Control Group p lt 0 0001 74 1 172 232 in the START Placebo Group p 0 0937 and 82 0 200 244 In the START Radiation Group p gt 0 9999 Freedom from TVR 6 month for RENO Long and WRIST Long WRIST and 8 month for START was 85 1 110 134 as compared to 39 4 37 94 in the WRIST Long Wrist Control Group p 0 0001 75 9 176 232 in the START Placebo Group p 0 0444 and 84 0 205 244 in the START Radiation Group p gt 0 8825 Additionally a comparison of the patients treated with stepping pullback or a single 60 mm source train with in the RENO Long Subgroup demonstrated that the proce dural success rate for the pullback group was 88 9 96 109 as compared to 93 3 28 30 in the 60 mm group Freedom from MACE 6 month was 81 0 85 105 for the pullback group as compared to 86 2 25 29 in the in the 60 mm group p 0 5963 Freedom from TVR 6 month was 83 8 88 105 for the pullback group as compared to 89 7 26 29 in the 60 mm group p 0 5639 A total of 139 patients of the 1098 enrolled in 46 cen ters in Europe were analyzed in the REN
87. ety Results All Patients Treated N 451 START 40 20 versus START Sr 90 START 40 20 START Sr 90 Relative Risk Difference Efficacy Measures N 207 Patients N 244 Patients 95 C l 95 C 1 P value 8 Month Stent Segment Binary Restenosis Rate 15 4 23 149 14 2 28 197 1 1 0 65 1 81 1 2 6 476 8 8 0 7507 8 Month Analysis Segment Binary Restenosis Rate 25 3 38 150 28 8 57 198 0 9 0 62 1 25 3 5 12 8 5 9 0 4738 at 240 Days 88 2 86 4 1 02 0 94 1 11 1 8 5 2 8 8 0 4516 TVR Free at 240 Days 83 1 83 5 1 00 0 91 1 09 0 4 8 1 7 4 0 8750 TVF Free at 240 Days 80 0 81 4 0 98 0 89 1 09 1 4 9 5 6 8 0 8724 MACE Free at 240 Days 80 0 81 4 0 98 0 89 1 09 1 4 9 5 6 8 0 8724 Target Lesion Success 95 7 198 207 99 6 243 244 1 0 0 93 0 99 3 9 6 8 1 0 0 0047 Procedure Success 93 7 194 207 97 1 237 244 1 0 0 93 1 01 3 4 7 3 0 5 0 0795 Device Success 96 6 200 207 98 4 240 244 1 0 0 95 1 01 1 7 4 7 1 2 0 2320 Post Procedure Stent Segment Minimal Lumen Diameter MLD in mm Meanz SD 2 09 0 40 196 2 17 0 42 242 0 08 0 16 0 00 0 0489 Range min max 1 02 3 33 1 12 3 47 PostProcedure Analysis Segment Minimal Lumen Diameter MLD in mm SD 1 84 0 39 196 94 0 39 243 0 10 0 17 0 03 0 0073 Range min 0 61 2 89 1 0
88. eub ye ee Ei INovoste START Trial a ceret eeu ere betae Table 1 Principal Effectiveness and Safety Results a eene eene erre Figure 1 Freedom from Target Vessel Failure at 12 months The START 40720 Trial acras eso ons coco eto n ta eode Table 2 Principal Effectiveness and Safety Results START 40 20 vs START placebo Table 3 Principal Effectiveness and Safety Results START 40 20 vs START 5 90 Figure 2 Freedom from Target Vessel Failure at 240 days ssssssssee eere enne RENG Long Sub Analysis sc uu nu ter hte Pep ree ERE Tide eoa Duration of combined antiplatelet regimen following VBT in the RENO Registry Table 4 Principal Effectiveness and Safety Results RENO Long vs WRIST Long Figure 3 6 month Freedom from Table 5 Principal Effectiveness and Safety Results RENO Long vs START Placebo Table 6 Principal Effectiveness and Safety Results RENO Long vs START Radiation Table 7 Principal Effectiveness and Safety Results Pullback vs Non Pullback 60 mm IV Insir ctions For Use u eerte ertet e tied seco iere se eoe e EE RON cen Detailed Device Description How
89. exposure of radia tion and or unintended results Vessel trauma may result from the improper use of the Delivery Catheter Follow the enclosed directions carefully When the Delivery Catheter is in the body it should be manipulated only under fluoroscopy Never advance or withdraw the Delivery Catheter against resistance without first determining the rea son for the resistance under fluoroscopy ystem components Do not over tighten the hemostatic valve as this may damage the Delivery Catheter and impede the path of the ACTIVE Source Train and may cause uninten tional exposure of radiation and or unintended results Failure to open the hemostatic valve may prevent the radiation source train from returning to the device and may result in unnecessary radiation exposure to the patient or personnel e Failure to correctly position the Source Train at the interventional injury site may underexpose the target ed treatment area and expose tissue not targeted for treatment to unintentional radiation unpredictable results may occur Exceeding the prescribed radiation treatment time will result in a higher than intended dose Migration or improper location of the Source Train may cause unintentional radiation osure to occur and may decrease treatment e icocy e Failure to comply with the specific use of the Transfer Device controls may result in injury or unintended radiation exposure Radiation is e
90. fer Device Green Features associated with the secured position in the Transfer Device green arrow light on or the successful return of the Source Train into the Transfer Device Amber Features associated with sending the Source Train from the Transfer Device into the Delivery Catheter and maintaining the Source Train in the Treatment Zone or when the Source Train has been moved out of the proper position within the Source Chamber Red Features associated with excessive or unsafe pressure being used with the Transfer Device The Transfer Device can be turned ON or OFF by depressing the Blue ON OFF button for 3 5 seconds When the ON OFF button is initially depressed the electronics will perform an LED light test indicated when all of the indicator lights alternately blink The system will automatically power off after 50 minutes when the gate is closed the ON OFF button has not been pressed and the Source Train has not been sent received If the system powers OFF during a procedure simply press the blue ON OFF button again to turn the device back ON The Transfer Device incorporates an electronic source sensing system that independently verifies the position of the Source Train Once the LED light test is completed either the Green or Amber Arrow Indicator light will remain illuminated depending on the position of the Source Train in the Source Chamber When the Source Train is properly positioned in the Transfer Device the
91. for Irrigation and push to apply forward pressure to the syringe plunger to return the LNON ACTIVE Source Train to the Source Chamber of the Non active Transfer Device b In the event the non active Source Train has not returned to the Source Chamber of the Nov Acrive Transfer Device perform the following Loosen the hemostatic valve with left hand Remove the Delivery Catheter from the patient leaving the guiding catheter and guidewire in lace return the NON ACTIVE Source Train to the NON ACTIVE Transfer Device and reattempt the procedure with a new Delivery Catheter fol lowing standard Test and Placement proce dures 6 While continuing to apply pressure on syringe slide the Gate Control Switch to the position 7 Unlock the LNON ACTIVE Transfer Device from the 8 Disconnect the Delivery Catheter from the Delivery Catheter by depressing the Proprietary Connector Lock Latch such that the blue line is no longer visible NON ACTIVE Transfer Device while maintaining Delivery Catheter 51 D03745Rev D 03 08 ETA CATH positioning at the targeted interventional injury site Disconnect the Delivery Catheter by depressing both squeeze tabs located on the Proprietary Connector while withdrawing the Proprietary Connector from the NON ACTIVE Transfer Device 9 Carefully place a sterile Proprietary C
92. g term safety of treatment with the Beta Cath System was evaluated by incidence of combined major adverse cardiac events MACE defined as death Q wave and non Q wave myocardial infarction Ml emergent coronary artery bypass graft CABG and target vessel revascularization TVR at 3 4 and 5 years post initial treatment Additionally the rate of aneurysm was reported to ensure that no late radiation effect was present Long term efficacy was evaluated by incidence of target vessel revascularization TVR and target lesion revascularization TLR at 3 4 and 5 years post initial treatment Clinical coordinators at each site collected the follow up data on standardized case report forms This data may have been collected via a telephone call to the patient or through a patient s hospital visit record Follow up data is presented in two ways outcomes by individual year and cumulative outcomes in which the number of patients experiencing an event by each year was calculated using the Kaplan Meier method Please note that data is unadjudicated Summary of 3 year Follow Up START Sr 90 vs START Placebo The 3 year MACE rate was 49 7 83 167 in the Sr 90 arm and 61 7 95 154 in the Placebo arm p 0 0332 The TVR rate was 43 1 72 167 in the Sr 90 arm and 56 5 87 154 in the Placebo arm p 0 0191 No new aneurysms were reported at the 3 year follow up for either group START Sr 90 vs START 40 20 The 3 year MACE rate was 49 7 83
93. guidewire as the guidewire may prolapse when the Delivery Catheter is withdrawn If this occurs attempt to resolve the prolapse by gently pulling back on the guidewire while simultaneously advancing the catheter If the prolapse persists disengage the Delivery Catheter from the guidewire by continuing to advance the Delivery Catheter while gently pulling back on the guidewire Exercise care when withdrawing the Delivery Catheter through any area of increased restriction such as a stent guide catheter tip or hemostatic valve Always withdraw the Delivery Catheter slowly and observe under fluoroscopy whenever possible The Transfer Device contains radioactive material Use of this device is restricted to persons licensed in the handling of radioactive materials Personnel handling this device must follow the regulations policies and procedures for their institution on the safety and hazards associated with radioactive materials Utilize a manual Blood Pressure Cuff to monitor patient status during the radiation treatment because arterial wave form pressure may be dampened while the Delivery Catheter is in place e Illumination of the Red Pressure Indicator A light dur ing a procedure indicates excessive pressure is being used reduce applied pressure to return to the Amber VA Pressure Indicator area Do not turn the Transfer Device power On or attempt to the Gate Control Switch during the Drying Procedure Failure to p
94. he START Trial were as follows Antiplatelet Duration Days Anticoagulant 0 14 15 30 31 60 Ticlopidine 9 50 3 250 500mq tay Clopidogrel 23 121 42 75mg day Ticlopidine Clopidogrel 0 0 0 145 patients received no additional antiplatelet therapy other than aspirin One patient received Ticlopidine for 30 days followed by Clopidogrel for 60 days One patient received Ticlopidine for 14 days followed by Clopidogrel for 155 days One patient received Ticlopidine for 7 days followed by Clopidogrel for an unconfirmed duration Clinical follow up occurred at in hospital 1 month and 8 months Angiographic follow up occurred at 8 months The study randomization was successful as both treatment groups were found to be demographically equivalent All randomized patients were included in the intentto treat analysis The principal effectiveness and safety results are presented in Table 1 followed by the freedom from target vessel failure Kaplan Meier curve Figure 1 The mean lesion length studied was 16 1mm with approximately 30 of the lesions greater than 19 mm e Novoste Table 1 Principal Effectiveness and Safety Results START Trial All Patients Treated N 476 Sr 90 Placebo Relative Risk Difference Efficacy Measures N 244 Patients N 232 Patients 95 C l 95 C I P value 8 Month Stent Segment Binary Restenosis Rate 14 2 28 197 41 2
95. heter Removal Disassembly of the System Post Procedural Radiation Checks Drying and Storing of the Transfer Devices Emergency Source Recovery Optional nsiruell nst uu uu ua aner EE eE E AEE EEE ne Ea arae E aani q Shape ls IST eiecti metet terree 2 In Vivo Transport of a NON ACTIVE Source Train AMETS EST m VI Beta Caihi 3 5 System Specilications aisne nu nre rt ER Fete emer na CH nee Peste eire Storage and Transport sssssse eem Attachment A Symbols and Graphics Used with the Beta Cath 3 5F System Attachment B Additional Dosimetry Information for the Beta Cath 3 5F System Estimated Dose to Patient Non Target Tissue and Clinicians in a Typical Procedure Dose Verificaliorts ic eise Dose DisiriBulie u kau ads a Figure 11 Relative Dose Rate from ACTIVE Source Train as a Function of Distance sssss Re Attachment C START amd START 40720 5 yeat Follow Up tent pen prt a Ri eio QU que FO OZECRm
96. inactive radiopaque marker at each end The Source Train provides the radiation dose during the treatment procedure The System Accessories are the ancillary components of the Beta Cath 3 5F System that 1 ensure sterility and facilitate operation of the system during a clinical proce dure 2 permit temporary storage of in the event of a disrupted clinical procedure 3 tacili tate handling of Source Train components if located out side of the System 4 facilitate Medical Physicist s opera tions and or 5 enable transport of the System compo nents and Medical Physicist s Kit The Beta Cath 3 5F System is intended to deliver beta radiation to the site of successful Percutaneous Coronary Intervention PCI for the treatment of in stent restenosis in native coronary arteries with discrete lesions treatable with a 20 mm balloon for the 30 mm and 40 mm Systems and injury areas up to 40 mm for the 60 mm System in a vessel diameter ranging from 2 7 mm to 4 0 mm Contraindications e Unprotected left main disease gt 50 narrowing e Patients in whom antiplatelet and or anticoagulant therapy are contraindicated Every attempt should be made to avoid re stenting of the target lesion to minimize the risk of thrombosis Delivery Catheter amp Source Train Placement Use of an Internal Mammary IM Artery Guide Catheter may impede the path of the ACTIVE Source Train and may cause unintentional
97. is procedure Place the shipping container packaging White Lead Lined Storage Container and Transfer Device in a secure location until the wipes have been evaluated Count the wipes with a method capable of detecting Sr Y contamination on the wipes Note results of the wipe readings along with their respective locations on objects in your Institution s Radiation Protection Records and in accordance with your institution s policies and or local regulations If the results of all the wipe tests are 200 dpm 100 or within locally determined level if desired perform a Device Leak Test see Section B below Insert the 6 Volt Lithium ion battery pack aged in the foam insert placed over the Transfer Device as described on page 31 After successfully completing the Leak Test place the Active Transfer Device in the White Lead Lined Storage Container and confirm that the black and yellow Radiation Warning symbol is on the White Lead Lined Storage Container Place the White Lead Lined Storage Container in the appropriate slot in the Transport Case and LOCK Only trained authorized persons should have access to the Transport Case and the key to the lock 37 D03745 Rev D 03 08 ETA CATH A ACTIVE Device Receipt Continued RO MP RSO D 13 Apply the Caution Radioactive Material Label or equivalent in accordance with local regulations or institutional policies and procedures on the Trans
98. ld be performed only due to the inad vertent movement or misplacement of the delivery catheter and not for additional radiation treatments Delivery Catheter Preparation 1 Remove the Delivery Catheter from the patient 2 Carefully place a sterile Proprietary Connector Cover over the tip of the Proprietary Connector to prevent contamination of the sterile field and place the Delivery Catheter onto the sterile prep table 3 Place a non absorbent backed sterile gauze pad under the Delivery Catheter Proprietary Connector to collect displaced non sterile water 4 Place several sterile gauze sponges around the Delivery Catheter Proprietary Connector and hold firmly 5 Have a non sterile assistant put on sterile gloves and perform the following Carefully uncoil the sterile IST Remove the Proprietary Connector Cover and discard Carefully insert the IST fully into the Delivery Catheter Proprietary Connector until the IST hub is fully seated against the hub of the Delivery Catheter Proprietary Connector PRECAUTION Displaced water is non sterile Discard contaminated gloves e Delivery Catheter e g PRECAUTION After the Delivery Catheter is attached to and primed with a Transfer Device the fluid within the Delivery Catheter and the tip of the Delivery Catheter Proprietary Connector portion inserted into the Transfer Device are no longer sterile Use care when handling the Delivery Catheter to
99. lesion was defined as target vessel revascularization at a site other than the target site with or without concomi tant target lesion revascularization lt Novoste 7 D03745 Rev D 03 08 III Essential Prescribing Information Adverse Events Continued Three 3 patients who received radiation died during the START trial The deaths occurred between 167 and 225 days One 1 patient died due to coronary artery dis ease congestive heart failure and multisystem dysfunc tion It could not be determined if the cause of death was device related The cause of death for the other two patients was determined not to be device related There were 476 patients treated with the Beta Cath 5F System BCS in the Stents and Radiation Therapy START Trial Device success defined as successful deliv ery and treatment with the BCS was achieved in 467 of the 476 patients 98 The table provided below out lines the details of the malfunctions reported as part of the treatment of the 476 patients The 108 patient treat ments with device malfunctions include 89 cases with minor device malfunctions 1O cases with initial device malfunctions with subsequent treatment success and 9 device failures preventing treatment success Summary of Device Malfunctions of Patients Number of patients enrolled in START Trial 476 Number of Cases with Device Malfunctions 108 Number of Cases with unsuccessful delivery and treatment with the
100. ling at least 300 cm2 labeling each wipe for the area assessed 3 Count the wipes with a method capable of detecting Sr Y contamination on the wipes 4 Note results of the wipe readings along with their respective locations on objects in your Institution s Radiation Protection Records and in accordance with te Novoste 8 your institution s policies and or local regulations Remove the tamper proof seal Remove the ring and the lid Remove the White Lead Lined Storage Container and wipe at least 100 cm of the outside of the container labeling the wipes accordingly WARNING Radiation is emitted from the ACTIVE Transfer Device when the Radiation Sources are in the Source Chamber To minimize hand dose the Transfer Device is designed to be held on the under side and may also be set down when appropriate Open the White Lead Lined Storage Container and remove the Transfer Device wiping at least 100 cm of the outside of the Transfer Device PRECAUTION If the transferable contamination exceeds 200 dpm 100 cm or the level determined by local regulation or institutional policy on any wipe place the contaminated object s in a plastic bag label Caution Radioactive Material and Immediately inform institutional Radiation Safety per sonnel implement containment control procedures and call your Best Vascular Representative Should this occur do not continue with th
101. longest in length Survival estimates from Kaplan Meier method Standard error estimate from Peto formula TLR free Freedom from target lesion revascularization TVR free Freedom from target vessel revascularization TVF free Freedom from death MI and target vessel revascularization a Novoste MACE free Freedom from death MI emergent CABG and target vessel revascularization In Hospital MACE Death Q wave or non Q wave MI emergent CABG or target vessel revascularization prior to discharge as determined by the independent Clinical Events Committee Outof Hospital MACE Death Q wave or non Q wave MI emergent CABG or target vessel revascularization from hospital discharge through the 240 day contact as determined by the independent Clinical Events Committee Stent thrombosis was defined as angiographic thrombus or subacute closure within the target vessel at the time of the clinically driven angiographic restudy for documented ischemia chest pain and ECG changes Any death not attributed to a non cardiac cause within the first 30 days was considered a surrogate for thrombosis in the absence of documented angiographic stent patency Site thrombosis was defined as myocardial infarction attributable to the target vessel with angiographic documenta tion sitereported or by QCA of thrombus or total occlusion at the target site gt 30 days after the index procedure in the absence of an intervening revascularization of the t
102. lso included follow up at 3 and 4 years Please refer to the START and START 40 20 data reported in the Essential Prescribing Information section of this IFU for more details on the trials The number of participating sites and subjects followed by year are shown below Summary of 5 year Follow Up START Sr 90 vs START Placebo The 5 year MACE rate was 62 6 97 155 in the Sr 90 arm and 67 8 101 149 in the Placebo arm p 0 3995 The TVR rate was 51 0 79 155 in the Sr 90 arm and 59 1 88 149 in the Placebo arm p 0 1678 No new aneurysms were reported at the 5 year follow up for either group START Sr 90 vs START 40 20 The 5 year MACE rate was 62 6 97 155 Table C1 Participating Sites and of Patients START and START 40 20 PAS START START 40 20 Participatin Enrolled Participating Enrolled g Sites Subjects Sites Subjects Original 50 476 22 207 Trial 3 Year 34 160 14 87 4 Year 35 174 13 83 5 Year 34 192 15 81 The purpose of the follow up was to evaluate the long term safety and efficacy of the Beta Cath System in patients who were enrolled in the START and START 40 20 trials for the treatment of in stent restenosis of native coronary arteries For the START Trial this included all subjects enrolled whether they received Sr 90 or placebo treatment Clinical status including documentation of clinical events and angina status was recorded at 3 4 and 5 years for patients Lon
103. min max 6 7 57 6 5 8 62 5 Follow Up Stent Segment Minimal Lumen Diameter MLD in mm SD N 1 96x0 66 197 1 47 0 60 187 0 49 0 36 0 62 0 0000 Range min max 0 00 3 45 0 00 2 65 Follow Up Analysis Segment Minimal Lumen Diameter MLD in mm SD N 1 65x0 64 198 1 41 0 58 188 0 24 0 12 0 36 0 0001 Ronge 0 00 3 18 0 00 2 66 Follow Up Stent Segment Percent Diameter Stenosis DS SD N 30 4 22 7 197 47 9 20 8 187 17 5 21 9 13 1 0 0000 Range min max 32 276 100 0 4 4 100 0 Follow Up Analysis Segment Percent Diameter Stenosis DS Meant SD N 41 7 20 7 198 50 1 19 7 188 8 5 12 5 4 4 0 0000 Range min 10 4 100 0 13 4 100 0 Safety Measures and Other Clinical Events to 240 days In Hospital MACE 2 5 6 244 2 2 5 232 1 1 0 35 3 69 0 3 2 4 3 0 0 8255 Out ofHospital MACE to 240 Days 16 0 39 244 24 1 56 232 0 7 0 46 0 96 8 2 15 3 1 0 0 0261 In and Out of Hospital MACE to 240 Days 18 0 44 244 25 9 60 232 0 7 0 49 0 98 27 8 15 2 0 4 _ 0 0388 Aneurysmt 0 5 1 198 0 0 0 188 0 5 0 5 1 5 0 3292 Stent Thrombosis to 30 days 0 0 0 244 0 4 1 232 0 0 0 4 1 3 0 4 0 3046 Site Thrombosis Days 31 240 0 0 0 244 0 0 0 232 12 0 0 Totol Occlusions 4 0 8 198 3 7
104. mitted from the Transfer Device when the Radiation Source Train is in the Source Chamber To minimize hand dose the Transfer Device is designed to be held on the underside and may also be set down when appropriate Intravascular Radiation Procedure If the fluid in the capped Fluid Collection Bag after the procedure is found to be contaminated after scanning then the Transfer Device and capped Fluid Collection Bag should be placed in the Temporary Storage Container Immediately inform Institutional Radiation Safety personnel implement contamination control procedures and call your Best Vascular Representative If at any time a Survey Meter reading of the Transfer Device Delivery Catheter Fluid Collection Bag or Procedure Room is significantly different from initial baseline readings stop all activity and re survey the Transfer Device Delivery Catheter Fluid Collection Bag or Procedure Room making sure the fluoroscopy is off If the reading is not within the acceptable baseline range or background range there may potentially be a misplaced source refer to Section Q Emergency Source Recovery Procedure UNDER NO CIRCUMSTANCES should an individual attempt to remove the Radiation Source Train from the Beta Cath 3 5F System grasp the catheter directly with hands when an active Radiation Source Train is being used cut the catheter or pick up a source with his her fingers because unintended radi ation exposure
105. mostatic valve with left hand Remove the Delivery Catheter from the patient leaving the guiding catheter and guidewire in place return the NON ACTIVE Source Train to the Novoste NON ACTIVE Transfer Device and reattempt the procedure with a new Delivery Catheter following standard Test and Placement procedures NON ACTIVE Source Train Return 1 2 Co Visually confirm that the Ensure that the hemostatic valve is open Move the Fluid Control Lever to Depress the syringe plunger so that all three Amber VA Pressure Indicator lights are illuminated during the return of the NovacrivE Source Train An audible click will be heard as the non active Source Train returns to the Source Chamber Maintain pressure on the syringe while visually con firming that the Non active Source Train is located within the Source Chamber and that the Green Arrow Indicator Light is ON NON ACTIVE Source Train is located in the Source Chamber and the distal radiopaque marker of the jacketed Source Train is clearly present In event that the entire Source Train cannot be confirmed to have returned to the NON ACTIVE Transfer Device perform the following Confirm the hemostatic valve is open e Confirm the Fluid Control Lever is in position Pull to withdraw approximately 1 ml Sterile Water
106. n D Ricciardello M Collins L Evaluation of radiation dose and risk to the patient from coronary angiography Aust NZ J Med 1998 597 603 Dose Verification Best Vascular calibrates each LACTVE Source Train with techniques and standards traceable to a National Institute of Standards and Technology NIST standard at 2 mm from the centerline of the ACTIVE Source Train Each Active Transfer Device is shipped with its own Calibration Certificate that provides the dose rate and associated treatment times Any instrument or dosimeter used to directly measure the dose rate from the crie Source Train must be small enough to measure the dose rate at 2 mm from the cen terline of the ACTIVE Source Train Radiation Personnel can utilize Radiochromic Film or a scintillation system which has the properties required for the measurement of absolute doses in very small volumes Dose Distribution The dose rate from the AcTvE Source Train is deter mined in water at 2 mm from the centerline of the Source Train The dose rate diminishes signifi cantly as the distance from the sources increases Figure 9 describes the relative dose rate as a function of dis tance from the centerline of the Source Train This data was obtained using Monte Carlo computer codes The graph demonstrates the advantage of using beta radia tion for the treatment of restenosis because tissues other than the injury site receive
107. ng Combined Of Hospital Events to 6 Months N 139 WRIST Control N 94 N 233 MACE 17 9 24 134 64 9 61 94 37 3 85 228 Death 2 2 3 134 2 1 2 94 2 2 5 228 MI Q or Non Q 1 5 2 134 17 0 16 94 7 9 18 228 Q wave MI 0 7 1 134 1 1 1 94 0 9 2 228 Non Qwave MI 0 7 1 134 16 0 15 94 7 0 16 228 TVR 14 9 20 134 60 6 57 94 33 8 77 228 TVPTCA 2 2 3 134 9 6 9 94 5 3 12 228 TV CABG 12 7 17 134 56 4 53 94 30 7 70 228 Beta Cath System is not indicated for pullback stepping sb Novoste 11 D03745 Rev D 03 08 ETA CATH RENO Long versus START Placebo Major Adverse Events In and Out of Hospital All Patients N 371 Combined In and Out RENO Long START Placebo Combined Of Hospital Events N 139 N 232 N 371 MACE 17 9 24 134 25 9 60 232 23 0 84 366 Death 2 2 3 134 0 4 1 232 1 1 4 366 MI 1 5 2 134 3 0 7 232 2 5 9 366 Quwave MI 0 7 1 134 0 0 0 232 0 3 1 366 Non G wave 0 7 1 134 3 0 7 232 2 2 8 366 TVR 14 9 20 134 24 1 56 232 20 8 76 366 12 7 17 134 14 7 34 232 13 9 51 366 2 2 3 134 10 3 24 232 7 4 27 366 RENO Long versus START Radiation Major Adverse Events In and Out of Hospital All Patients N 383 Combined In and Out RENO Long START Radiation Combined Of Hospital Events N 139 N 244 N 383 MACE
108. non Q wave MI emergent CABG or target vessel revascularization prior to discharge as determined by the independent Clinical Events Committee 5 Novoste OutofHospital MACE Death Q wave or non Q wave MI emergent CABG or target vessel revascularization from hospital discharge through the 240 day contact as determined by the independent Clinical Events Committee Stent thrombosis was defined as angiographic thrombus or subacute closure within the target vessel at the time of the clinically driven angiographic restudy for documented ischemia chest pain and ECG changes Any death not attributed to a non cardiac cause within the first 30 days was considered a surrogate for thrombo sis in the absence of documented angiographic stent patency Site thrombosis was defined as myocardial infarction attributable to the target vessel with angiographic documen tation site reported or by QCA of thrombus or total occlusion at the target site gt 30 days after the index pro cedure in the absence of an intervening revascularization of the target vessel Aneurysm was defined as an expansion of the lumen by at least 20 compared with the normal lumen dimen sions in the treatment region analyzed segment that extends with a wide or narrow mouth beyond the apparent normal contour Baseline QCA for patient 15 3 revealed the presence of an aneurysm The Angiographic Core Laboratory reported the absolute size of the aneurysm changed very little from baselin
109. nufacturer s instructions For further assistance see your Best Vascular representative 6 0 Volt Lithium lon Battery PRECAUTION Do not recharge disassemble expose to high temperatures or incinerate the provid ed Transfer Device battery Keep in package until ready to use Dispose of used battery properly 31 D03745 Rev D 03 08 ETA CATH Figure 4 Beta Cath 3 5F System Radiopaque P Tip Marker Indicator of Source Train IST pre loaded in Catheter A Guidewire Exit Port 1 cm from tip B Rail 3 5F Internal Radiopaque Delivery Marker dark Catheter Source Train Stop e 4 ae x 5 5 lt Connector 4 7 2E 0X amp Y as da S Z i L Df 9 e Beta Cath 3 5F System Transfer Device P Y e b w ij e Novoste D03745 Rev D 03 08 ETA CATH Table 8 Transfer Device Controls and Indicators Figure 5 ON OFF BUTTON Blue Low Battery Indicator Amber Light Connector Lock Latch Blue Line Source Train Arrow Indicator Lights Green and Amber Gate Control Switch Source Chamber Viewing Window The ON OFF button activates the electronic circuitry for approximately 50 minutes When first switched ON the electronics will perform a self diagnostic test with all indicator lights alternately blinking on and off for approximately 5 seconds then returning t
110. o ensure proper engagement with the Transfer Device 3 Connect a Fluid Collection Bag 4 Connect a 20 ml syringe filled with air to the Syringe Luer e Novoste 5 Ensure that the Fluid Control Lever is in Baa Rapidly flush the Transfer Device with air pausing at the end to allow all air flush to be expelled 7 Remove the Syringe refill with air and repeat air flush 3 5 times until all noticeable fluid is removed 8 Remove the Fluid Collection Bag and Flushing Adapter Cleaning and Storing Procedure 1 Insert the Quartz Cap into the Proprietary Connector receptacle of the Transfer Device 2 Place the Syringe Cap onto Syringe of the Transfer Device 3 Remove any visible debris from the surface by wiping the outside of the Transfer Device with a cloth damp ened with water 4 Place the Transfer Device in the appropriate storage con tainer and store in accordance with institutional policy Q Emergency Source kro MP RSO D Train Recovery This procedure provides guidance for recovering an Source Train when it cannot be confirmed to have reached the injury site will not return to the Transfer Device or has escaped the containment of the System This docu ment provides direction for the user to safely return the ACTIVE Source Train to a controlled location REQUIRED MATERIALS Gloves non sterile Response Kit Water Four or more saline soaked gauze s
111. o their normal power state The Transfer Device can be turned OFF by depressing the ON OFF button for 3 5 seconds PRECAUTION f the self diagnostic test is not observed do not use the device and call your Best Vascular Representative for service Under normal power conditions once the ON OFF button has been activated the Low Battery Indicator will blink for approximately 5 seconds and then go off When battery power is low the Low Battery Indicator light will continue to blink PRECAUTION Do not begin a procedure if the Low Battery light is blinking If the Low Battery Indicator starts blinking during a procedure there will be enough battery power to complete the procedure Replace the battery per instructions found on page 31 of this User s Manual When the Latch locks the Proprietary Connector into the Transfer Device the lock prevents disengagement of the Delivery Catheter from the Transfer Device The Proprietary Connector is locked by fully depressing the white Proprietary Connector Lock Latch The Latch is fully extended when a Blue line is visible on the Proprietary Connector Lock Latch To unlock depress the Lock Latch in the opposite direction so the blue line is no longer visible The Proprietary Connector can only be disen gaged from the Transfer Device when the Proprietary Connector is unlocked AND the Source Train is located in the Source Chamber with the Green Arrow Indicator light on There
112. on IF resistance is felt reposition the proprietary connector to ensure proper engagement with the Transfer Device 4 Continue procedure per Section J ACTIVE Transfer Device Priming 2 In Vivo Transport of aINON ACTIVE Source Train RO D The following is the procedure for performing in vivo trans port of a Source Train e g as a test of in vivo Delivery Catheter source train lumen patency This optional Po is only intended to be when required institutional procedures and when The Delivery Catheter has been properly prepared per Section E Delivery Catheter Inspection Preparation The Delivery Catheter has been placed ot the inter ventional injury site per Section F Placement of the Delivery Catheter The Delivery Catheter s pre loaded IST has been removed per Section G IST Removal and Delivery Catheter positioning across the interven tional iun site has been maintained as con firmed by fluoroscopy Note Use only a Novoste NON ACTIVE 3 5F System compatible Transfer Device Catalog Number TDN 6040 when performing this procedure NON ACTIVE Transfer Device Preparation 1 Follow the same Transfer Device preparation steps as outlined in Section H or ACTIVE Transfer Device Preparation NON ACTIVE Transfer Device Priming 1 Follow the same instructions as found in Section J ACTIVE Transfer Device Priming
113. onnector Cover over the tip of the Proprietary Connector to prevent contamination of the sterile field 10 Carefully return the non active Transfer Device to the sterile prep table 11 Proceed with Section H or ACTIVE Transfer Device Preparation Note Before performing step H 8 1 4 to insert the Delivery Catheter Proprietary Connector into the acrive Transfer Device conduct the following actions Confirm appropriate position of the Delivery Catheter using fluoroscopy Remove and discard the Proprietary Connector Cover from the tip of the Proprietary Connector V Customer Service Information To reorder supplies call for repair service or to report an adverse event device failure or complaint contact Best Vascular Inc 4350 International Blvd Norcross Georgia 30093 USA Tel 1 800 Novoste Fax 1 770 717 1283 59 Novoste D03745 Rev D 03 08 ETA CATHD VI Beta Cath 3 5F System Specifications B Rail 3 5F DELIVERY CATHETER Single use Sterile by ethylene oxide and Non pyrogenic BRail 3 5F Delivery Catheter overall length 180 cm BRail 3 5F XL Delivery Catheter overall length 267 cm Outer Diameter 3 5F 1 17 mm 0 046 Catheter Markings External Proximal Depth Marker 100 cm from distal tip At Most Distal Point Stop Internal Radiopaque of Source Train Marker dark Internal Radiopaque Tip Marker light At
114. oon and a 30 mm Source Train 95 using the Beta Cath 5F System The observed adverse events are summarized in the following table Major Adverse Events In Hospital and Out of Hospital to 8 months All Patients Treated N 476 Sr 90 Placebo All Randomized N 244 Patients N 232 Patients N 476 Patients Combined In and Out of Hospital Complications to 240 Days Number 76 Number Number Any MACE Death MI Emergent CABG TVR 44 18 0 60 25 9 104 21 8 Death 3 1 2 0 4 4 0 8 Myocardial Infarction Q or Non Q 4 1 6 7 3 0 11 2 3 Q Wave MI 0 0 0 0 0 0 0 0 0 Non Q Wave MI 4 1 6 7 3 0 1 2 3 Emergent CABG 1 0 4 0 0 0 1 0 2 Target Lesion Revascularization 32 13 1 52 22 4 84 17 6 TL CABG 20 8 2 24 10 3 44 9 2 TLPTCA 12 4 9 30 12 9 42 8 8 Target Vessel Revascularization not involving the TL 1 4 5 15 6 5 26 5 5 TV CABG 2 0 8 2 0 9 4 0 8 TV PTCA 9 3 7 13 5 6 22 4 6 Target Vessel Revascularization 39 16 0 56 24 1 95 20 0 TV CABG 21 8 6 24 10 3 45 9 5 TV PTCA 19 7 8 34 14 7 53 11 1 Stent Thrombosis to 30 days 0 0 0 1 0 4 1 0 2 Site Thrombosis Days 31 240 0 0 0 0 0 0 0 0 0 Abrupt Closure 0 0 0 1 0 4 1 0 2 Subacute Closure 0 0 0 1 0 4 1 0 2 Bleeding Complicotions 4 1 6 4 1 7 8 1 7 Vosculor Complicotions 4 1 6 3 1 3 7 1 5 CVA 1 0 4 1 0 4 2 0 4 Target vessel revascularization not involving the target
115. operly drying cleaning and storing the LACTIVE Transfer Device following a procedure Only trained authorized person nel should perform this procedure The following materials are required to complete the procedure ACTIVE ACTIVE Transfer Device containing the Source Train Medical Physicist s Kit Response Kit e Survey meter Clean towels e Non sterile gloves Preparation 1 The Authorized Personnel responsible for cleaning the Transfer Device should put on gloves and then obtain the Transfer Device 2 Survey the Transfer Device and note results 3 Visually inspect and confirm that the jacketed Source Train is present in the Transfer Device and that the Gate Control Switch is in the position Drying Procedure PRECAUTION Do not turn the Transfer Device power ON or attempt to the Gate Control Switch during the Drying Procedure PRECAUTION Use only the 3 5F compatible Flushing Adapter provided with the Beta Cath 3 5F System Use of any other Beta Cath Flushing Adapter will result in an improper fit and an inabili ty to properly perform the Drying Procedure 1 Insert the Flushing Adapter 3 5F compatible into the Transfer Device 2 Secure y depressing the Proprietary Connector Lock Latch PRECAUTION Do not force the connector lock latch into osition If resistance is felt reposition the 3 5F compati Dle Flushing Adapter t
116. ose Profiles Along the Axis of the 30 mm Source Train at Various Radial Distances in Water E401 u 4 3mm Distance from the 4mm axis of the SES mm Source Train E 00 9 6 mm 7 mm m 8 mm E01 E 02 relative dose rate normalized to 1 0 at 2 mm E 03 20 15 10 5 0 5 10 15 20 Distance along a 30 mm Source Train mm centered at zero Dose Profiles Along the Axis of the 40 mm Source Train at Various Radial Distances in Water P E 01 3mm Distance from the 44mm axis of the 5mm Source Train E 00 6 mm X 7 mm m 8 mm E01 E 02 relative dose rate normalized to 1 0 at 2 mm E 03 25 20 15 10 5 0 5 10 15 20 25 Distance along a 40mm source train mm centered at zero Dose Profiles Along the Axis of the 60 mm Source Train at Various Radial Distances in Water A La La a aL i iy A a AI I E P AEE 1 E 01 Distance from the axis of the 00 Source Train 1 E 01 1 E 02 relative dose rate normalized to 1 0 ot 2 mm 1 E 03 3 5 3 2 5 2 1 5 1 0 5 0 0 5 1 1 5 2 2 5 3 3 5 Distance along a 60mm source train mm centered at zero 7 Gn Novoste D03745 Rev D 03 08 Attachment C START and START 40 20 5 year Follow Up All 50 sites that participated in the START Trial and 22 sites that participated in the START 40 20 Trial were asked to follow patients for the 5 year Post Approval Studies PAS which a
117. ource Train back into the Transfer Device The Fluid Control Lever should always be maintained in the position except when sending the Sources to the treatment area The electronic sensing circuitry and Pressure Indicator lights sense the pressure delivered by the operator when depressing the syringe to Hold the Source Train The first Amber Pressure Indicator light identified by TX illuminates when ade quate pressure is applied to maintain Source Train positioning during treatment The second Amber Pressure Indicator light identified by YA will illuminate when additional pressure is applied Illumination of this light without the Third Amber Pressure Indicator Light during the Send and Return indicates adequate pressure is being applied to move the Source Train The third Amber Pressure Indicator light identified by Y will illuminate when more pressure is applied To send or return the Source Train enough pressure must be applied to keep in the range identified by the arrows next to the second an third Pressure Indicator lights see Fig 5 where both the second and third Amber indicator lights are illuminated The fourth Pressure Indicator light which is red identified by a caution symbol will illuminate when too much pressure is applied Pressure should be reduced to the 2nd or 3rd Amber Pressure Indicator light areas when sending and retrieving the Sources If excessive pressure continues there may not be adequate fl
118. patients with angina or posi tive functional study were identified for elective treatment of in stent restenosis in a native coronary artery lesion visually estimated to be between 2 7 and 4 0 mm in diameter and treatable with up to a 20 mm length angioplasty balloon These patients underwent success ful percutaneous coronary interventions defined as revascularization by balloon angioplasty directional and rotational atherectomy and excimer laser after which treatment with the 40 mm Beta Cath 5F System was administered After the vascular brachytherapy treat ment additional percutaneous coronary interventional techniques or devices were utilized as deemed necessary by the clinician Placement of a new stent while discour aged occurred at the discretion of the clinician in 15 3 n 31 207 of the cases Radiation was pre scribed according to the following reference vessel diam eter gt 2 7 lt 3 35 mm received 18 4 Gy and gt 3 35 lt 4 0 mm received 23 Gy at a distance 2 mm from the centerline of the source train 18 4 and 23 Gray reflect the NIST recommended adjustments to the documented doses as described in Technical Report DSGN 0311 A and are equivalent to the 16 and 20 Gray documented doses described in the START 40 20 Trial e Novoste The Antiplatelet Anticoagulant regimen administered for the 207 patients in the START 40 20 Trial were as follows Antiplatelet Duration Days Unconfirmed An
119. ponges pads Survey Meter Whole body and extremity personnel dosimeters for the individual performing the recovery Temporary Storage Container WARNING Should Breach of Train containment occur Notify personnel present of missing Source Train No personnel should be allowed to enter or leave the room until the Source Train is con tained Individuals involved in Source Train recovery should wear disposable gloves an extremity dosimeter on the hand expected to receive the highest dose and a whole body dosimeter on the front of the body between the neck and the waist UNDER NO CIRCUMSTANCES should an individual pick up the Source Train with his her fingers because unintended radiation exposure and injury may result Required equipment is provided for this purpose in the Response Kit ACTIVE Source 47 D03745 Rev D 03 08 ETA CATH If the AcTivE Source Train does not return to the Transfer Device and if the Delivery Catheter has not been disconnected from the LAcTIVE Transfer Device the ACTIVE Source Train is considered to be lodged in the Catheter If the Catheter has not been withdrawn from the patient the Cardiologist should immediately perform the following maneuver to with draw the entire Beta Cath 3 5F System e Loosen the hemostatic valve with left hand Use four or more saline soaked gauze sponges to grasp and remove the
120. port Case 14 Store the Transport Case in a secure area designat ed for storage of radioactive materials in accor dance with the institution s requirements B Radioactive Sealed Source Device Leak Test Procedure RO MP RSO D Required Materials e Active Transfer Device e Flushing Adapter e Fluid Collection Bag Syringe Sterile Water for Irrigation PRECAUTION Use only Sterile Water for Irrigation which may also be referred to as sterile distilled non pyrogenic water in the Transfer Device Do not use saline as a hydraulic fluid in the Transfer Device corrosion may occur Only trained authorized personnel should perform this procedure After performing the Device Receipt Procedure to assess transferable contamination if desired perform the following procedure for the Transfer Device Refer to the Transfer Device Controls and Indicators on Page 33 and the ACTIVE Transfer Device diagram on Page 35 to become familiar with the compo nents 1 Remove caps from Transfer Device and place in White Lead Lined Storage Container 2 Insert the 3 5F compatible Flushing Adapter 3 5F compatible Flushing Adapter supplied in the Medical Physicist s Kit and secure into the Proprietary Connector receptacle of the Transfer Device by depressing the white Proprietary Connector Lock Latch until it is fully extended and a blue line is visi ble on the Latch 3 5F compatible Flushing Ada
121. pter PRECAUTION Use only the 3 5F compatible Flushing Adapter provided with the Beta Cath 3 5F System Use of any other Beta Cath Flushing Adapter will result in an improper fit and an inability to properly perform the Leak Test Procedure PRECAUTION Do not force the connector lock latch into position If resistance is felt reposition the 3 5F compati ble Flushing Adapter to ensure proper engagement with the Transfer Device 3 Connect a Fluid Collection Bag to the Fluid Collection Bag Luer Port of the Transfer Device 4 Connect a 20 ml syringe filled with approximately 5 ml of water to the Syringe Luer of the Transfer Device 5 Ensure that the Fluid Control Lever of the Transfer Device is in ESI ACTIVE 6 Flush 5 ml of water through the Transfer Device 7 Disconnect the syringe fill with 5 ml of air and recon nect to Transfer Device and flush 5 ml of air through the AcTvE Transfer Device 8 Disconnect the syringe and the Flushing Adapter from the Transfer Device 9 Disconnect the Fluid Collection Bag from the ACTIVE Transfer Device and cap the Fluid Collection Bag 10 There are two acceptable methods for counting the fluid to determine the radioactive content a If a liquid scintillation counter is used add the scin tillation cocktail to the scintillation vial and add the water from the Fluid
122. rdm P Value Wilcoxon 6 05 1 0 0139 Log Ronk 6 90 1 0 008 gi ep Novoste D03745 Rev D 03 08 ETA CATH The START 40 20 Trial The START 40 20 STents And Radiation Therapy Trial a multicenter prospective registry trial began in June 1999 The START 40 20 Trial studied the treatment of lesions treatable with a 20 mm balloon with a 40 mm Source Train using the Beta Cath 5F System The acute and 8 month clinical and angiographic results showed that the procedure success rate defined as the attainment of a residual stenosis of 5096 without in hos pital major adverse cardiac events MACE death Q wave and non G wave MI emergent CABG and target vessel revascularization was 93 7 194 207 The Kaplan Meier estimate of freedom from MACE ot 8 months was 80 0 The Kaplan Meier estimate of free dom from target vessel failure TVF defined as target vessel revascularization MI or death at 8 months was 80 0 A total of 207 patients were enrolled at 22 US and European investigational sites in the START 40 20 Trial All 207 of the enrolled patients received the active AO mm Beta Cath 5F System The primary end point of 8 month clinical target vessel failure was defined as the composite of death myocardial infarction Q wave and non Q wave coronary artery bypass graft surgery CABG and revascularizations attributed to the target vessel TVR A clinical events committee adjudicated all major endpoints Eligible
123. red ACTIVE Transfer Device to pre posi tioned Delivery Catheter PRECAUTION The inside portion of the tape cover ing the Proprietary Connector Port Hole is not sterile remove from the sterile field to avoid compromise of ster ile field Wet tip of the Delivery Catheter Proprietary Connector with Sterile Water for Irrigation to ease insertion and insert the Proprietary Connector of the Delivery Catheter through the distal hole of the Sterile Bag into the Proprietary Connector Receptacle of the Transfer Device Rotate Proprietary Connector to ensure a secure connection PRECAUTION When attaching the Proprietary Connector to the Transfer Device use care to ensure that the Proprietary Connector does not catch the Sterile Bag during insertion 9 Lock the Proprietary Connector to the Transfer Device by fully the Proprietory Lock Lotch until blue line is visible PRECAUTION Do not force the connector lock latch into position If resistance is felt reposition the propri etary connector to ensure proper engagement with the Transfer Device Note Continue to Section J l Transfer Device Preparation with the 6 Rail 3 5F XL Delivery Catheter RO D Note This section is intended for using the Transfer Device outside the sterile field with the B Rail 3 5F XL Delivery Catheter only When using the Transfer Device inside the sterile field follow Section H W
124. remove from the sterile field 5 Insert the Syringe with Extension Connector into the Syringe Port Hole and tighten to Syringe Note To use Fluid Management System Connect a Merit Medical High Pressure 200 psi minimum Injection Line or Best Vascular valified equivalent to Luer connect Merit Medical 3 way Stopcock 200 psi minimum to High Pressure line and connect a syringe to each port on the stopcock Turn stopcock ON to the primary syringe and proceed with prep ping procedure below The User may elect to not use the stopcock and connect the syringe directly onto the high pressure extension tubing See Figure lo 9 Novoste ETA CATHD PRECAUTION When attaching the syringe or extension tubing to the Transfer Device use care to ensure that the syringe hub does not pinch the Sterile Bag during the process Do not over tighten the syringe when connecting the Extension Connector to the Syringe Luer Figure 10 Fluid Management System Novoste Transfer Device a Merit Medical High Pressure Line I Merit Medical 20 p x Syringe i f Control Syringe p i y ka i Merit Medical 3 Way SE d f la or Best Vascular qualified equivalent Align the distal Centering Ring over the Proprietary Connector Receptacle of the Active Transfer Device Remove the tape covering the distal hole of the Sterile Bag 7 Bring prepa
125. rom the 40 mm Beta Cath System is 0 13 of the annual dose limit and the estimated dose from the 60 mm Beta Cath 3 5F System is 0 2 of the annual dose limit Skin dose is defined here as the dose received to the unprotected hand only not the whole body dose Clinician Whole Body Dose per Treatment Fluoroscopy during PTCA 4 to 16 mrem 0 04 to 0 16 5 30 mm Beta Cath 3 5F System 0 2 mrem 0 002 mSv 40 mm Beta Cath 3 5F System 0 3 mrem 0 003 mSv 60 mm Beta Cath 3 5F System 0 4 mrem 0 004 mSv No dose reduction applied for a lead apron Annual Whole Body Dose Limit for Occupational Workers 5 000 mrem 50 mSv The estimated dose from the 30 mm Beta Cath 3 5F System is 0 004 of the annual dose limit the estimated dose from the 40 mm Beta Cath 3 5F System is 0 006 of the annual dose limit and the estimated dose from the 60 mm Beta Cath 3 5F System is 0 008 of the annual dose limit Cath Lab Staff Whole Body Dose per Treatment 30 mm Beta Cath 3 5F System 0 03 mrem 0 0003 mSv 40 mm Beta Cath 3 5F System 0 04 mrem 0 0004 mSv 60 mm Beta Cath 3 5F System 0 06 mrem 0 0006 mSv No dose reduction applied for a lead apron Annual Whole Body Dose Limit for Occupational Workers 5 000 mrem 50 mSv The estimated dose per procedure from the 30 mm Beta Cath 3 5F System is 0 0006 of the annual dose limit the estimated dose per procedure from the 40 mm Beta
126. ry Catheter exclusively to the Novoste Beta Cath 3 5F System compatible Transfer Device How Supplied The initial Beta Cath 3 5F System shipment will include the following items e ACTIVE Transfer Device and White Lead Lined Container in a Type A shipping container e Start Up Kit which contains the following items One Transport Case which includes One Response Kit One Temporary Storage Container One 5 pack box of Medical Physicist s Kits The B Rail 3 5F Delivery Catheter which includes the Procedure Accessory Pack supplied sterile is sold sepa rately All items are also sold individually a3 Novoste ETA CATH Reusable Items ACTIVE Transfer Device The Transfer Device containing the ACTIVE Source Train will be shipped to the hospital aside a White Lead Lined Storage Container in a Type A for shipping radioactive material shipping container The Transfer Device should be received by radiation personnel of the institution according to local regulations and institutional radiation procedures After the radiation safety personnel perform the incoming Device Receipt Procedure the White Lead Lined Storage Container containing the ACTIVE Transfer Device with the Source Train should be placed in the Transport Case for movement within your institution and secured from unauthorized access gt s The Transport Case is a plastic
127. scular Inc Prepare another Delivery Catheter for use begining with Section E Delivery Catheter Inspection Preparation 3 Gently remove the IST from the Delivery Catheter while maintaining the position of the Delivery Catheter under fluoroscopy 4 Coil wire portion of IST into 2 3 loops and fold ends inside loops for temporary use H Transfer Device Preparation with the 6 Rail 3 5F Delivery Catheter RO D Note Follow the instructions in this section when using the Transfer Device inside the sterile field with the BRail 3 5F or B Rail 3 5F XL Delivery Catheter If using the Transfer Device outside the sterile field with the B Rail 3 5F XL Delivery Catheter see Section 1 WARNING Radiation is emitted from the LACTIVE Transfer Device when the Radiation Sources are in the Source Chamber To minimize hand dose the Transfer Device is designed to be held on the under side and may also be set down when appropriate 1 Once the appropriate Beta Cath 3 5F System compat ible Transfer Device Source Train is selected based upon the interventional injury length and desired mar gin coverage confirm the following ACTIVE Transfer Device conditions The radioactive warning symbols are on the device The Gate Control Switch is in the position e The distal radiopaque marker of the Source Train is away from the Gate The Fluid Control Lever is set to Th
128. status during radiation treatment 13 Monitor the amount of Sterile Water for ately Irrigation in the Syringe and the Fluid Collection Confirm the hemostatic valve is open Bag Confirm the Fluid Control Lever is in Note If using Fluid Management System turn stop position cock to secondary syringe if additional fluid is required or replace with a filled syringe prior to returning the ACTIVE Source Train Pull to withdraw approximately 1 ml Sterile Water for Irrigation and push to apply for ward pressure to the syringe plunger to return the 2m Source Train to the Source Chamber of the Transfer Device 99 Novoste 45 D03745 Rev D 03 08 ETA CATH b In the event the LACTIVE Source Train has not N Disassembly of the System MP RSO D returned to the Source Chamber of the Transfer Device after 15 seconds has elapsed since When the complete system has been removed from initiating the return of the Source Train immediate the patient visually confirm that the Source ly perform the following maneuver to withdraw the Train is contained in the Source Chamber of the entire Beta Cath 3 5F System Transfer Device and the distal radiopaque loosen the hamasta e wale with band marker of the jacketed Source Train is clearly pre sent Use four or more saline soaked gauze sponges 2 Unlock the Transfer Device from the Deliver P y t one remove th
129. sterile A Sterile Bag is pro vided to maintain a sterile field during the procedure The inside portion of the tape covering the Syringe Port Hole and the Proprietary Connector Port Hole of the sterile bag is not sterile remove from the sterile field Do not recharge disassemble expose to high tem peratures or incinerate the provided Transfer Device battery Keep in package until ready to use Dispose of used battery properly The Transfer Device requires scheduled maintenance by Best Vascular within a period not to exceed twelve months Refer to each Transfer Device s Calibration Certificate for its specified use period Please contact your Best Vascular Representative to arrange for service Use the Delivery Catheter and Procedure Accessory Pack before the expiration date noted on the pack age Verify that the sterility of the devices has not been compromised by assuring the package integri ty has been maintained The Delivery Catheter and Procedure Accessory Pack items are intended for sin gle use Do not re sterilize and or reuse these items Do not use if sterile package is damaged Use only Sterile Water for Irrigation which may also be referred to as sterile distilled non pyrogenic water in the Transfer Device Do not use saline as a hydraulic fluid in the Transfer Device corrosion may occur Do not use the Delivery Catheter if there is evidence of damage Damaged catheters may cause vessel trauma or unpre
130. t Segment Binary Restenosis Rate 15 4 23 149 41 2 77 187 0 4 0 25 0 57 25 7 34 9 16 6 _ 0 0000 8 Month Analysis Segment Binary Restenosis Rate 25 3 38 150 45 2 85 188 0 6 0 41 0 77 19 9 29 8 9 9 0 0002 TLR Free at 240 Days 88 2 75 6 1 17 1 05 1 29 12 6 4 4 20 8 0 0008 TVR Free at 240 Days 83 1 73 8 1 13 1 01 1 26 9 3 0 6 18 1 0 0174 TVF Free at 240 Days 80 0 72 276 1 11 0 98 1 25 7 8 1 2 16 976 0 0559 MACE Free at 240 Days 80 0 72 2 1 11 0 98 1 25 7 8 1 2 16 9 0 0559 Target Lesion Success 95 7 198 207 99 19 230 232 1 0 0 93 1 00 3 5 6 5 0 5 0 0197 Procedure Success 93 7 194 207 97 0 225 232 1 0 0 93 1 01 3 3 7 2 0 7 0 1017 Device Success 96 6 200 207 97 8 227 232 1 0 0 96 1 02 1 2 4 3 1 9 0 4315 PostProcedure Stent Segment Minimal Lumen Diameter MLD in mm Mean SD N 2 09 0 40 196 2 15 0 42 229 0 06 0 14 0 02 0 1292 Range min max 1 02 3 33 1 20 3 40 PostProcedure Analysis Segment Minimal Lumen Diameter MLD in mm Means SD NJ 1 842 0 39 196 1 94 0 41 230 0 10 0 18 0 03 0 0078 Range min max 0 61 2 89 0 98 3 10 PostProcedure Stent Segment Percent Diameter Stenosis DS Means SD 23 8 15 7 196 22 9 12 9 229 0 8 1 9 3 6 0 5432 Range min max 13 476 66 0 19 676 51 9 PostProcedure Analysis Segment Percent Diameter Stenosis DS Means SD N 33 2
131. t the entire Source Train is located within the Source Chamber and that the Green Arrow Indicator light is ON Note Once the Source Train is located within the Source Chamber of the ACTIVE Transfer Device the Delivery Catheter can be removed and the proce dure restarted with a new Delivery Catheter following standard Test and Placement procedures c In the event the Lactive Source Train has not reached the treatment site or been returned to the Source Chamber of the ACTIVE Transfer Device after 15 seconds has elapsed since initiating the send of the Source Train immediately perform the following maneuver to withdraw the entire Beta Cath 3 5F System e Loosen the hemostatic valve with left hand Use four or more saline soaked gauze sponges to grasp and remove the Delivery Catheter and guidewire from patient Place Delivery Catheter and ACTIVE Transfer Device still attached into Temporary Storage Container Refer to Section Q Emergency Source Train Recovery Procedure for further instructions ETA CATHD WARNING Avoid direct contact with unshielded 14 Ensure that sufficient pressure is applied such that the radiation sources in the Delivery Catheter as unin first TX Amber Pressure Indicator light remains on tended radiation exposure will occur during treatment 15 Use fluoroscopy approximately every 15 30 seconds and cine with con
132. theter is sig nificantly different from the initial background read ing stop all activity and re survey the Deliver Catheter making sure the fluoroscopy is off If the reading is not within the acceptable background range then refer to Section Q Emergency Source Recovery Procedure 7 When requested remove the ACTIVE Transfer Device from the White Lead Lined Storage Container Remove Caps from the Transfer Device Inventory and record that all components of the Source Train are present prior to giving the ACTIVE Transfer Device to the Radiation Oncologist RO Note When conducting the room survey during the patient treatment the operator s hand holding the Survey Meter should be covered with a sterile cover to maintain a sterile field The sterile cover should be extended and secured at the operator s elbow Additionally this person should observe all procedures relating to sterile tech nique and avoid any contact with the sterile field E Delivery Catheter Inspection Preparation PRECAUTION The Delivery Catheter and Procedure Accessory Pack items are intended for single use Do not re sterilize and or reuse these items Do not use if sterile package is damaged Open the Delivery Catheter and the Procedure Accessory Pack onto the sterile field PRECAUTION Use only Sterile Water for Irrigation which may also be referred to as sterile distilled non pyrogenic water
133. ticoagulant 2 3 4 lt 30 days 31 60 61 90 gt 90 Ticlopidine 4 0 0 2 0 250 500mg day Clopidogrel 38 2 72 37 10 75mg day Ticlopidine Clopidogrel 0 1 0 2 0 11 patients received no antiplatelet therapy 26 patients received no additional antiplatelet therapy other than aspirin One patient had unconfirmed antiplatelet therapy One patient received Coumadin Endo Products Inc for gt 90 days One patient received Clopidogrel for 21 days followed by Ticlopidine for 14 days One patient received Ticlopidine for 14 days followed by Clopidogrel for 30 days and one patient received Ticlopidine for 30 days followed by Clopidogrel for 90 days Clinical follow up occurred at in hospital 1 month and 8 months Angiographic follow up occurred at 8 months The patients in the START 40 20 Trial were compared to the START Sr 90 and START Placebo groups The princi pal effectiveness and safety results are presented in Tables 2 and 3 followed by the freedom from target vessel failure Kaplan Meier curve Figure 2 The mean lesion length studied was 17 4 mm 17 D03745Rev D 03 08 Table 2 Principal Effectiveness and Safety Results All Patients Treated N 439 START 40 20 versus START Placebo START 40 20 START Placebo Relative Risk Difference Efficacy Measures N 207 Patients N 232 Patients 95 C l 95 C I P value 8 Month Sten
134. trast media at least once during the WARNING Do not grasp catheter directly with radiation treatment to confirm and record the proper hands or cut the catheter as unintended radiation position of the Active Source Train across the inter exposure may result ventional injury site L Source Train Return RO D 8 Cine with contrast medium to document placement of the ACTIVE Source Train 1 Check for adequate 10 ml minimum fluid volume in WARNING Failure to correctly position the syringe ACTIVE Source Train at the interventional injury site Note If using Fluid Management System turn stop may underexpose the targeted treatment area and cock fo secondary syringe if additional fluid is expose tissue not targeted for treatment to uninten required or replace with a filled syringe prior to tional radiation unpredictable results may occur returning the Source Train 2 Ensure that the hemostatic valve is open 9 Maintain placement of the Active Source Train at the Treatment Zone for the prescribed period of time by opplying continuous r pressure Adequate WARNING Failure to the hemostatic pressure is indicated y the illumination of the first valve may prevent the radiation source train from Amber TX Pressure Indication Light returning to the device and may result in unin tended radiation exposure to the patient or WARN
135. uid vol ume remaining in the syringe to complete the procedure PRECAUTION Do not use the Transfer Device if the controls and indicators are not functioning correctly Please contact your Best Vascular for service PRECAUTION The Transfer Device requires scheduled maintenance by Best Vascular within a period not to exceed twelve months Refer to each Transfer Device s Calibration Certificate for its specified use period Please contact your Best Vascular representative to arrange for service a Novoste ETA CATHD Figure 5 ACTIVE Beta Cath 3 5F System Transfer Device 60 mm Version Shown Proprietary Connector Receptacle Distal Radiopaque Source Train Marker Proprietary Connector Lock Latch Locked Gate Control Switch a in Position Close i rk i Jacketed Source Train Source Li Chomber A Proximal Radiopaque Source Train Marker SEND Amber Arrow Indicotor Light Out in Green Arrow T B tnt Light Fluid Control Lever IN p in Position La Syringe Luer On Off Button Pressure Indicotor Lights Low Battery Indicator Cn O Ix M B Novoste Fluid Collection Bag Luer Ag Novoste s D03745 Rev D 03 08 ETA CATH Procedure Flow Therapy Plannning CARD RO MP RSO D Section C Page 39 Surveillance of the Cath Lab Room Delivery Catheter Inspection Preparation RO MP RSO D CARD
136. y balloon inflations stent deployment or debulking devices Filming with contrast medium the deflated balloon positions and the start and end positions of debulking devices will help define the injury length The dose and treatment time is then deter mined by matching the artery reference vessel diameter with the reference vessel diameter ranges provided on the Calibration Certificate Figure 6 IST Marker Positions Active Train Length 60mm The radiopaque markers of the Indicator of Source Train 20 define the radioactive segment for each respective Source Train Selection of a 30 mm Transfer Device will provide for 5 mm margins and selection of a 40 mm or a 60 mm Transfer Device will provide for 10 mm margins Figure 7 Appropriate Radiation Coverage Radiation Source Train RST Proximal i il Distal radiopaque marker radiopaque marker Coronary ey 20 mm PTCA gt balloon Mardin Injury Length Recommended Radiation Coverage Margin 5 mm margins for 30 mm RST 10 mm margins for 40 mm RST 10 mm margins for 60 mm RST 39 D03745 Rev D 03 08 ETA CATH D Surveillance of the Cath Lab Room RO MP RSO D The following Radiation Surveillance Procedure is sug gested for use with the Beta Cath 3 5F System in the Cath Lab Institutional procedures or local requirements may require alternative procedures The following materials

Beta-Cath™ 3.5F User`s Manual

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Beta-Cath&trade; 3.5F User`s Manual

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Beta-Cath™ 3.5F User`s Manual